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EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases

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ClinicalTrials.gov Identifier: NCT00848510
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal and Ovarian Cancer Patients With Liver Metastases
Intervention Biological: EMD 525797
Enrollment 41
Recruitment Details First/last participant (informed consent): Feb2009/Sep 2013. Study completion date: 28 Nov 2013. The study was conducted at 2 centers in United Kingdom and Spain.
Pre-assignment Details Enrolled: 61 screened for eligibility; 20 excluded (mainly non-fulfillment of inclusion or exclusion criteria), 41 participants were enrolled into the study.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version (RECIST) Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Period Title: Overall Study
Started 10 13 8 10
Completed 10 13 8 10
Not Completed 0 0 0 0
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg Total
Hide Arm/Group Description Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Total of all reporting groups
Overall Number of Baseline Participants 10 13 8 10 41
Hide Baseline Analysis Population Description
All subjects analysis set included all subjects who entered the trial (that is, all subjects who signed informed consent).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 13 participants 8 participants 10 participants 41 participants
61.6  (11.13) 58.9  (9.94) 68.9  (10.68) 57.8  (16.58) 61.2  (12.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 8 participants 10 participants 41 participants
Female
5
  50.0%
6
  46.2%
3
  37.5%
8
  80.0%
22
  53.7%
Male
5
  50.0%
7
  53.8%
5
  62.5%
2
  20.0%
19
  46.3%
1.Primary Outcome
Title Number of Subjects With Dose Limiting Toxicities (DLTs)
Hide Description Toxicity was graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring during the first 4 weeks of treatment (that is, until the beginning of Week 5, with the exception of Grade 3 asymptomatic increase in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase [ALP]) returning to Baseline within 7 days.), at any dose level, for which a causal relationship to the investigative medicinal product could not be ruled out by the Investigator and/or the Sponsor.
Time Frame Up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Dose escalation analysis set included all subjects in the safety analysis set who experienced any DLT during the DLT observation period, regardless of the number of investigational medicinal product (IMP) administrations and subjects who received the IMP at Weeks 1, 3, and 5 for Cohort 1 and at Weeks 1 and 3 for all other cohorts.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 6 12 6 7
Measure Type: Number
Unit of Measure: Subjects
1 1 0 2
2.Primary Outcome
Title Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls
Hide Description Volume transfer coefficient was defined as the volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow. Volumetric transfer coefficient was measured by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). DCE-MRI is a noninvasive quantitative method of investigating microvascular structure and function by tracking the pharmacokinetics of injected low molecular weight contrast agents as they pass through tumor vasculature.
Time Frame Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 8 12 8 10
Mean (Standard Deviation)
Unit of Measure: min^-1
Screening 1 0.233  (0.0817) 0.214  (0.1385) 0.221  (0.0991) 0.141  (0.0650)
Screening 2 0.253  (0.1219) 0.177  (0.1450) 0.176  (0.0851) 0.137  (0.0602)
Week 1 Day 2 0.227  (0.0869) 0.175  (0.1048) 0.180  (0.0769) 0.136  (0.0676)
Week 1 Day 5 0.227  (0.0934) 0.165  (0.1154) 0.171  (0.0665) 0.132  (0.0723)
Week 2 Day 1 0.209  (0.0992) 0.171  (0.1039) 0.194  (0.0938) 0.156  (0.0687)
3.Primary Outcome
Title Blood Plasma Volume and Extravascular/Extracellular Volume
Hide Description Blood plasma volume and extracellular/extravascular volume was measured using DCE-MRI.
Time Frame Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 8 12 8 10
Mean (Standard Deviation)
Unit of Measure: milliliter
Blood Plasma Volume: Screening 1 0.024  (0.0162) 0.014  (0.0071) 0.020  (0.0122) 0.022  (0.0183)
Blood Plasma Volume: Screening 2 0.024  (0.0125) 0.013  (0.0060) 0.020  (0.0252) 0.016  (0.0092)
Blood Plasma Volume: Week 1 Day 2 0.019  (0.0078) 0.014  (0.0090) 0.015  (0.0114) 0.020  (0.0191)
Blood Plasma Volume: Week 1 Day 5 0.026  (0.0155) 0.017  (0.0080) 0.013  (0.0082) 0.023  (0.0252)
Blood Plasma Volume: Week 2 Day 1 0.028  (0.0201) 0.019  (0.0087) 0.019  (0.0220) 0.020  (0.0164)
Extravascular Volume: Screening 1 0.319  (0.0649) 0.385  (0.1246) 0.345  (0.1352) 0.313  (0.0993)
Extravascular Volume: Screening 2 0.302  (0.0559) 0.319  (0.1007) 0.307  (0.0860) 0.307  (0.0808)
Extravascular Volume: Week 1 Day 2 0.283  (0.0464) 0.335  (0.1202) 0.330  (0.0723) 0.327  (0.0714)
Extravascular Volume: Week 1 Day 5 0.271  (0.0531) 0.327  (0.1162) 0.336  (0.1080) 0.312  (0.0924)
Extravascular Volume: Week 2 Day 1 0.286  (0.0700) 0.316  (0.1125) 0.345  (0.0803) 0.297  (0.0636)
4.Primary Outcome
Title Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60)
Hide Description IAUC 60 was used to give a gross indication of the delivery and uptake of contrast agent within the tumor (indicating the degree of perfusion and endothelial permeability. IAUC60 was measured using DCE-MRI.
Time Frame Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 8 12 8 10
Mean (Standard Deviation)
Unit of Measure: (Millimoles/liter)*sec
Screening 1 21.900  (6.0987) 20.844  (8.8439) 22.752  (8.2156) 16.602  (7.9627)
Screening 2 21.155  (6.4053) 17.670  (9.0159) 19.437  (8.5201) 16.168  (6.9961)
Week 1 Day 2 22.513  (6.8728) 18.140  (8.1305) 18.724  (6.6599) 17.607  (9.2052)
Week 1 Day 5 21.006  (5.7951) 17.557  (9.9606) 18.758  (5.1517) 16.313  (9.0325)
Week 2 Day 1 20.356  (6.6613) 18.498  (8.4957) 20.201  (7.1768) 17.314  (7.5539)
5.Primary Outcome
Title Whole Tumor Volume and Enhancing Tumor Volume
Hide Description Tumor volume (three-dimensional measurement) and the enhancing fraction of the tumor, which provides a gross measure of the proportion of the tumor that has a measurable level of perfusion, were assessed using DCE-MRI.
Time Frame Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 8 12 8 10
Mean (Standard Deviation)
Unit of Measure: Cubic millimeter (mm^3)
Whole Tumor Volume: Screening 1 180310.380  (254443.5241) 83921.304  (85983.0790) 58662.341  (49075.1555) 58665.247  (101041.3892)
Whole tumor volume: Screening 2 195939.314  (268158.6384) 73940.030  (81243.6227) 57573.776  (48175.9173) 63694.678  (121709.7593)
Whole tumor volume: Week 1 Day 2 188556.463  (260719.8741) 76214.685  (84401.6466) 62941.056  (56871.6273) 68159.203  (122487.7558)
Whole tumor volume: Week 1 Day 5 195172.560  (264976.6619) 72302.778  (79746.9479) 68160.675  (61512.3298) 74122.030  (135359.3601)
Whole tumor volume: Week 2 Day 1 200316.632  (271342.9822) 84412.235  (95360.1124) 76755.877  (75170.5945) 75468.633  (142025.4967)
EnhancingTumor Volume: Screening 1 173882.006  (243514.1367) 71043.485  (73510.7915) 58160.983  (49084.1307) 32790.886  (17602.3758)
Enhancing tumor volume: Screening 2 190189.883  (259044.1496) 70835.730  (75748.1887) 56818.305  (48373.6133) 68940.184  (118913.2150)
Enhancing tumor volume: Week 1 Day 2 184552.465  (254423.3623) 71323.352  (76071.6880) 61519.396  (55375.5040) 70147.221  (117332.7409)
Enhancing tumor volume: Week 1 Day 5 189836.185  (256862.4972) 71293.696  (75853.1409) 66927.883  (61671.2327) 74973.916  (133033.3585)
Enhancing tumor volume: Week 2 Day 1 206074.402  (270622.8624) 83616.930  (92140.5994) 75835.576  (75420.1670) 41201.278  (25012.0230)
6.Secondary Outcome
Title Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Hide Description An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame From the initiation of the trial treatment until 30 days after last administration of trial treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of IMP administration.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 10 13 8 10
Measure Type: Number
Unit of Measure: Subjects
TEAEs 10 13 8 10
Serious TEAEs 5 7 5 7
TEAEs leading to Discontinuation 1 2 1 2
TEAEs Leading to Death 0 1 2 1
7.Secondary Outcome
Title Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit
Hide Description Tumor response was assessed by the Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria. Tumor response was defined as the presence of a “best overall response” of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: At least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions. The qualification of a CR or of a PR needed a confirmation by a second computed tomography (CT) scan at least 4 weeks after the first scan. Best overall response was derived programmatically as the best response recorded from the first investigation medicinal product administration until disease progression. Clinical benefit was defined as the presence of a “best overall response” of complete response or partial response or stable disease lasting at least 6 weeks.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all subjects who received at least one dose of IMP administration. “N” signifies the total number of participants evaluable for this outcome measure. Same subjects may be reported in more than one category.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 8 11 7 6
Measure Type: Number
Unit of Measure: Subjects
CR 0 0 0 0
PR 0 0 0 0
SD 0 2 1 0
Progressive Disease 8 9 6 5
Not Assessable 0 0 0 1
Tumor Response 0 0 0 0
Clinical Benefit 0 2 1 0
8.Secondary Outcome
Title Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score
Hide Description The number of subjects who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.
Time Frame Up to 4 weeks after last dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of IMP administration.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 10 13 8 10
Measure Type: Number
Unit of Measure: Subjects
4 8 4 5
9.Secondary Outcome
Title Number of Subjects With Positive Binding Abituzumab Antibodies
Hide Description Subjects were defined as abituzumab positive if at least one positive result of antibodies against abituzumab was observed. In all other cases, subjects were defined as abituzumab negative.
Time Frame Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration)
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis set included all subjects who received at least one dose of study drug administration and provided sufficient data from the antibodies samples. 'N' (number of subjects analyzed) signifies the subjects evaluable for this outcome measure. "n" signifies the number of subjects evaluable for each time point, respectively.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 9 11 7 7
Measure Type: Number
Unit of Measure: Subjects
Week 1 Day 1 (n=9,11,7,7) 0 1 0 0
Week 3 Day 1 (n=9,11,7,7) 1 0 2 0
Week 5 Day 1 (n=6,9,6,2) 0 1 0 0
Week 6 Day 1 (n=0,6,5,2) 0 0 0 0
Week 7 Day 1 (n=0,5,5,2) 0 0 0 0
Week 8 Day 1 (n=4,0,0,0) 0 0 0 0
Week 11 (n=0,1,3,0) 0 0 0 0
EOS Visit (n=6,3,2,1) 1 0 0 0
10.Secondary Outcome
Title Progression-Free Survival (PFS) Time
Hide Description PFS was defined as the time from first study drug intake until radiological progression (based on RECIST Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Subjects without event were censored on the date of last tumor assessment. Investigator read was the assessment of all imaging by the treating physician at the local trial site.
Time Frame Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who received at least one dose of IMP administration.
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description:
Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
Overall Number of Participants Analyzed 10 13 8 10
Median (Full Range)
Unit of Measure: months
1.22
(0 to 1.3)
0.77
(0 to 7.6)
1.40
(1 to 10.7)
1.08
(0 to 1.2)
Time Frame From the initiation of the trial treatment until 30 days after last administration of trial treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Hide Arm/Group Description Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator. Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
All-Cause Mortality
Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/10 (50.00%)   7/13 (53.85%)   5/8 (62.50%)   7/10 (70.00%) 
Cardiac disorders         
Myocardial ischaemia * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  1/10 (10.00%) 
Abdominal pain upper * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Ascites * 1  2/10 (20.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Constipation * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Gastrointestinal haemorrhage * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
General disorders         
Pyrexia * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  3/10 (30.00%) 
Asthenia * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  1/10 (10.00%) 
Disease progression * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia * 1  0/10 (0.00%)  2/13 (15.38%)  0/8 (0.00%)  0/10 (0.00%) 
Cholangitis * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Hepatic failure * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Immune system disorders         
Drug hypersensitivity * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  2/10 (20.00%) 
Infections and infestations         
Biliary tract infection * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Hepatobiliary infection * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Investigations         
International normalised ratio increased * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders         
Dehydration * 1  1/10 (10.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant ascites * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Nervous system disorders         
Haemorrhage intracranial * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Hemiparesis * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abituzumab 250 mg Abituzumab 500 mg Abituzumab 1000 mg Abituzumab 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   13/13 (100.00%)   8/8 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/10 (0.00%)  1/13 (7.69%)  3/8 (37.50%)  1/10 (10.00%) 
Hypochromic Anaemia * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Lymphadenopathy * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Eye disorders         
Lacrimation Increased * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders         
Abdominal Distension * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Abdominal Pain * 1  1/10 (10.00%)  2/13 (15.38%)  2/8 (25.00%)  3/10 (30.00%) 
Abdominal pain upper * 1  1/10 (10.00%)  1/13 (7.69%)  0/8 (0.00%)  1/10 (10.00%) 
Anal haemorrhage * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Ascites * 1  2/10 (20.00%)  3/13 (23.08%)  0/8 (0.00%)  0/10 (0.00%) 
Constipation * 1  0/10 (0.00%)  4/13 (30.77%)  4/8 (50.00%)  1/10 (10.00%) 
Diarrhoea * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  2/10 (20.00%) 
Dyspepsia * 1  1/10 (10.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Dysphagia * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Flatulence * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  1/10 (10.00%) 
Gastrooesophageal reflux disease * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Nausea * 1  1/10 (10.00%)  3/13 (23.08%)  3/8 (37.50%)  4/10 (40.00%) 
Toothache * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  2/10 (20.00%) 
Vomiting * 1  1/10 (10.00%)  3/13 (23.08%)  0/8 (0.00%)  1/10 (10.00%) 
General disorders         
Asthenia` * 1  0/10 (0.00%)  2/13 (15.38%)  4/8 (50.00%)  3/10 (30.00%) 
Early Satiety * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Fatigue * 1  2/10 (20.00%)  2/13 (15.38%)  1/8 (12.50%)  5/10 (50.00%) 
Influenza like illness * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Localised oedema * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Oedema * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
oedema peripheral * 1  1/10 (10.00%)  2/13 (15.38%)  0/8 (0.00%)  2/10 (20.00%) 
Pain * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Pyrexia * 1  2/10 (20.00%)  1/13 (7.69%)  1/8 (12.50%)  0/10 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Hepatic pain * 1  2/10 (20.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Hepatomegaly * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Immune system disorders         
Drug hypersensitivity * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Infections and infestations         
Bacterial vaginosis * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Infection * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Lower respiratory tract infection * 1  1/10 (10.00%)  1/13 (7.69%)  0/8 (0.00%)  1/10 (10.00%) 
Oral Candidiasis * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  3/10 (30.00%) 
Oral Herpes * 1  1/10 (10.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Respiratory tract infection * 1  0/10 (0.00%)  1/13 (7.69%)  1/8 (12.50%)  0/10 (0.00%) 
Rhinitis * 1  1/10 (10.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Upper respiratory tract infection * 1  1/10 (10.00%)  1/13 (7.69%)  1/8 (12.50%)  0/10 (0.00%) 
Urinary tract infection * 1  1/10 (10.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications         
Fall * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Investigations         
Aspartate aminotransferase increased * 1  2/10 (20.00%)  1/13 (7.69%)  1/8 (12.50%)  2/10 (20.00%) 
Blood alkaline phosphatase increased * 1  3/10 (30.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Blood bilirubin increased * 1  0/10 (0.00%)  1/13 (7.69%)  2/8 (25.00%)  1/10 (10.00%) 
Blood cholesterol increased * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Blood creatinine increased * 1  1/10 (10.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Blood potassium increased * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Electrocardiogram Qt prolonged * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Eosinophil count increased * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Haemoglobin decreased * 1  3/10 (30.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
International normalised ratio increased * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Platelet count decreased * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders         
Cachexia * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Decreased appetite * 1  0/10 (0.00%)  3/13 (23.08%)  3/8 (37.50%)  4/10 (40.00%) 
Hypoalbuminaemia * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Hypokalaemia * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Hyponatraemia * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Hypophosphataemia * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Back pain * 1  1/10 (10.00%)  0/13 (0.00%)  1/8 (12.50%)  1/10 (10.00%) 
Musculoskeletal pain * 1  0/10 (0.00%)  1/13 (7.69%)  1/8 (12.50%)  0/10 (0.00%) 
Myalgia * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  2/10 (20.00%) 
Neck pain * 1  0/10 (0.00%)  1/13 (7.69%)  1/8 (12.50%)  0/10 (0.00%) 
Pain in extremity * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Peritumoural oedema * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Nervous system disorders         
Dizziness * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  1/10 (10.00%) 
Headache * 1  2/10 (20.00%)  4/13 (30.77%)  0/8 (0.00%)  2/10 (20.00%) 
Lethargy * 1  1/10 (10.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Somnolence * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Psychiatric disorders         
Anxiety * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Renal and urinary disorders         
Bladder Spasm * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Dysuria * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Polyuria * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Proteinuria * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Reproductive system and breast disorders         
Pelvic pain * 1  0/10 (0.00%)  0/13 (0.00%)  2/8 (25.00%)  1/10 (10.00%) 
Vulvovaginal pruritus * 1  0/10 (0.00%)  1/13 (7.69%)  0/8 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/10 (10.00%)  2/13 (15.38%)  1/8 (12.50%)  0/10 (0.00%) 
Dysphonia * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  2/10 (20.00%) 
Dyspnoea * 1  1/10 (10.00%)  1/13 (7.69%)  1/8 (12.50%)  1/10 (10.00%) 
Hiccups * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Nasal congestion * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Oropharyngeal pain * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Pleural effusion * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Productive cough * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  2/10 (20.00%) 
Pulmonary haemorrhage * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Rhinorrhoea * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Dermatitis alergic * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Dry skin * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  1/10 (10.00%) 
Eczema * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Night sweats * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Pruritus * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Pruritus generalised * 1  1/10 (10.00%)  0/13 (0.00%)  0/8 (0.00%)  0/10 (0.00%) 
Rash * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Rash erythematous * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Rash macular * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Rash maculo-papular * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Rash pruritic * 1  0/10 (0.00%)  0/13 (0.00%)  1/8 (12.50%)  0/10 (0.00%) 
Vascular disorders         
Flushing * 1  0/10 (0.00%)  0/13 (0.00%)  0/8 (0.00%)  1/10 (10.00%) 
Hot flush * 1  2/10 (20.00%)  1/13 (7.69%)  1/8 (12.50%)  0/10 (0.00%) 
Hypertension * 1  0/10 (0.00%)  2/13 (15.38%)  1/8 (12.50%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00848510     History of Changes
Other Study ID Numbers: EMR 62242-003
2008-001820-30 ( EudraCT Number )
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: July 24, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015