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A Study of EMD525797 in Solid Tumor Patients in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01327313
First received: March 30, 2011
Last updated: April 8, 2016
Last verified: April 2016
Results First Received: April 8, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Tumor
Intervention: Biological: EMD525797

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EMD525797 250 mg 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
EMD525797 500 mg 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
EMD525797 1000 mg 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
EMD525797 1500 mg 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.

Participant Flow:   Overall Study
    EMD525797 250 mg     EMD525797 500 mg     EMD525797 1000 mg     EMD525797 1500 mg  
STARTED     8     6     6     7  
COMPLETED     8     6     6     7  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The all-subjects set included all the subjects who signed the informed consent and were treated.

Reporting Groups
  Description
EMD525797 250 mg 250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
EMD525797 500 mg 500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
EMD525797 1000 mg 1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
EMD525797 1500 mg 1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
Total Total of all reporting groups

Baseline Measures
    EMD525797 250 mg     EMD525797 500 mg     EMD525797 1000 mg     EMD525797 1500 mg     Total  
Number of Participants  
[units: participants]
  8     6     6     7     27  
Age  
[units: years]
Mean (Standard Deviation)
  53.4  (11.64)     60.5  (4.42)     54.7  (14.32)     57.3  (10.81)     56.3  (10.69)  
Gender  
[units: participants]
         
Female     2     3     3     4     12  
Male     6     3     3     3     15  



  Outcome Measures
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1.  Primary:   Number of Subjects With Dose-limiting Toxicities (DLTs)   [ Time Frame: Baseline up to Week 4 ]

2.  Primary:   Maximum Observed Serum Concentration (Cmax): After Single Dose   [ Time Frame: Pre-dose, hour 1(end of infusion [EOI]), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

3.  Primary:   Maximum Observed Serum Concentration (Cmax) of EMD 525797:After Multiple Dose   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

4.  Primary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Single Dose   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

5.  Primary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Multiple Dose   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

6.  Primary:   Total Body Clearance (CL) of EMD 525797: After Single Dose   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

7.  Primary:   Total Body Clearance at Steady State (CLss) of EMD 525797   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

8.  Primary:   Apparent Volume of Distribution (Vz): After Single Dose   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

9.  Primary:   Pharmacokinetics of EMD 525797 - Trough Values   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

10.  Primary:   Apparent Volume of Distribution: After Multiple Dose   [ Time Frame: Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

11.  Secondary:   Number of Subjects With Overall Tumor Response   [ Time Frame: Baseline up to Week 36 ]

12.  Secondary:   Number of Subjects With Clinical Benefit   [ Time Frame: Baseline up to Week 36 ]

13.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From first dosing date until disease progression or death, maximum up to Week 36 ]

14.  Secondary:   Apparent Terminal Half Life (t1/2): After Single Dose   [ Time Frame: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

15.  Secondary:   Apparent Terminal Half Life (t1/2): After Multiple Dose   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

16.  Secondary:   Time to Maximum Observed Serum Concentration (Tmax): After Single Dose   [ Time Frame: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

17.  Secondary:   Time to Maximum Observed Serum Concentration (Tmax): After Multiple Dose   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

18.  Secondary:   Elimination Rate Constant (λz): After Single Dose   [ Time Frame: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

19.  Secondary:   Elimination Rate Constant ( λ z): After Multiple Dose   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

20.  Secondary:   Minimum Observed Serum Concentration (Cmin) After Multiple Doses   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

21.  Secondary:   Observed Serum Concentration Immediately Before Next Dosing (Cpre)   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

22.  Secondary:   Average Serum Concentration at Steady State (Cav)   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

23.  Secondary:   Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Single Dose   [ Time Frame: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

24.  Secondary:   Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Multiple Dose   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

25.  Secondary:   Volume of Distribution at Steady State (Vss)   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

26.  Secondary:   Mean Residency Time (MRT0-inf)   [ Time Frame: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 ]

27.  Secondary:   Mean Residence Time at Steady State (MRTss)   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

28.  Secondary:   Percentage Peak-Trough Fluctuation (PTF)   [ Time Frame: Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5 ]

29.  Secondary:   Accumulation Ratio (Rac)   [ Time Frame: Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 and Week 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01327313     History of Changes
Other Study ID Numbers: EMR200017-007
Study First Received: March 30, 2011
Results First Received: April 8, 2016
Last Updated: April 8, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency