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Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

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ClinicalTrials.gov Identifier: NCT00318370
Recruitment Status : Completed
First Posted : April 26, 2006
Results First Posted : February 15, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Morphotek

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Interventions Drug: Farletuzumab
Drug: Chemo Plus Far
Enrollment 58

Recruitment Details The first 6 participants enrolled in this study were dosed at farletuzumab, 37.5 mg/m2. The next 6 participants were dosed at farletuzumab, 62.5 mg/m2. The remaining participants received farletuzumab, 100 mg/m2.
Pre-assignment Details  
Arm/Group Title Far Only Chemo Plus Far Maintenance Far Only
Hide Arm/Group Description Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2). Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle. Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
Period Title: Period 1
Started 28 0 0
Completed 21 [1] 0 0
Not Completed 7 0 0
Reason Not Completed
Lack of Efficacy             5             0             0
Physician Decision             1             0             0
Withdrawal by Subject             1             0             0
[1]
21 participants proceeded from Far Only to Chemo Plus Far.
Period Title: Period 2
Started 0 47 [1] 0
Completed 0 36 0
Not Completed 0 11 0
Reason Not Completed
Adverse Event             0             3             0
Lack of Efficacy             0             5             0
Physician Decision             0             1             0
Withdrawal by Subject             0             1             0
Other             0             1             0
[1]
26 participants enrolled directly into Chemo Plus Far plus 21 participants from Far Only.
Period Title: Period 3
Started 0 0 36
Completed 0 0 3
Not Completed 0 0 33
Reason Not Completed
Adverse Event             0             0             1
Lack of Efficacy             0             0             24
Death             0             0             1
Physician Decision             0             0             1
Withdrawal by Subject             0             0             3
Other             0             0             3
Arm/Group Title Far Only and Chemo Plus Far and Maintenance Far Only
Hide Arm/Group Description

Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).

Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far.

Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
63.2  (11.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
54
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native 0
Asian 5
Native Hawaiian or Other Pacific Islander 0
Black or African American 1
White 44
More than one race 0
Unknown or Not Reported 0
Hispanic 4
1.Primary Outcome
Title Serologic Response (Change in CA125 Level)
Hide Description Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Time Frame Baseline to response (up to 30 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled to initial farletuzumab only.
Arm/Group Title Far Only
Hide Arm/Group Description:
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
2
(0.9 to 23.5)
2.Primary Outcome
Title Serologic Response (Change in Cancer Antigen [CA-125] Level)
Hide Description Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Time Frame Baseline to response (up to 27 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled to chemotherapy plus farletuzumab.
Arm/Group Title Chemo Plus Far
Hide Arm/Group Description:
Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
41
3.Secondary Outcome
Title Time to Serologic Response (Change in CA-125 Level)
Hide Description Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.
Time Frame Baseline to response (up to 27 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled to intial chemotherapy plus farletuzumab.
Arm/Group Title Chemo Plus Far
Hide Arm/Group Description:
Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: Weeks
3.3
(3.1 to 6.1)
4.Secondary Outcome
Title Duration of Serologic Response (CA-125)
Hide Description Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being >2 X ULN on two occasions.
Time Frame Baseline to response (up to 44 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled to initial chemotherapy plus farletuzumab.
Arm/Group Title Chemo Plus Far
Hide Arm/Group Description:
Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(9.9 to NA)
[1]
NA = Not Estimable because the median number of participants did not progress or die.
5.Secondary Outcome
Title Overall Response Rate
Hide Description The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, “complete response” (CR), “partial response” (PR), “stable disease” (SD), or “progressive disease” (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.
Time Frame Baseline to response (up to 44 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemo Plus Far
Hide Arm/Group Description:
Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response 6.8
Partial Response 63.6
Stable Disease 20.5
Progressive Disease 4.5
Not Evaluable 6.8
6.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 >2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.
Time Frame Baseline to response (up to 44 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.
Arm/Group Title Chemo Plus Far Plus Maintenance Far Only
Hide Arm/Group Description:

Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.

Maintenace Far Only: farletuzumab, 100 mg/m2

Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: Months
10.2
(7.4 to 13.1)
7.Secondary Outcome
Title Percentage of Participants Who Had a Prolongation of Remission
Hide Description Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator’s assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.
Time Frame Baseline to response (up to 44 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.
Arm/Group Title Chemo Plus Far Plus Maintenance Far Only
Hide Arm/Group Description:

Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.

Maintenace Far Only: farletuzumab, 100 mg/m2

Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.6
(13.0 to 42.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Far Only and Chemo Plus Far and Maintenance Far Only
Hide Arm/Group Description

Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).

Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far.

All-Cause Mortality
Far Only and Chemo Plus Far and Maintenance Far Only
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Far Only and Chemo Plus Far and Maintenance Far Only
Affected / at Risk (%)
Total   20/54 (37.04%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  2/54 (3.70%) 
Thrombocytopenia  1  2/54 (3.70%) 
Anaemia of chronic disease  1  1/54 (1.85%) 
Leukopenia  1  1/54 (1.85%) 
Cardiac disorders   
Acute coronary syndrome  1  1/54 (1.85%) 
Aortic valve stenosis  1  1/54 (1.85%) 
Coronary artery disease  1  1/54 (1.85%) 
Gastrointestinal disorders   
Abdominal Pain  1  2/54 (3.70%) 
Diarrhoea  1  2/54 (3.70%) 
Large intestinal obstruction  1  2/54 (3.70%) 
Subileus  1  2/54 (3.70%) 
Constipation  1  1/54 (1.85%) 
Rectal haemorrohage  1  1/54 (1.85%) 
Small intestinal obstruction  1  1/54 (1.85%) 
Vomiting  1  1/54 (1.85%) 
General disorders   
Adverse drug reaction  1  1/54 (1.85%) 
Chest discomfort  1  1/54 (1.85%) 
Injection site reaction  1  1/54 (1.85%) 
Hepatobiliary disorders   
Portal vein thrombosis  1  1/54 (1.85%) 
Immune system disorders   
Cytokine release syndrome  1  1/54 (1.85%) 
Infections and infestations   
Urosepsis  1  2/54 (3.70%) 
Clostridium colitis  1  1/54 (1.85%) 
Diverticulitis  1  1/54 (1.85%) 
Pneumonia  1  1/54 (1.85%) 
Injury, poisoning and procedural complications   
Wound dehiscence  1  1/54 (1.85%) 
Investigations   
Psychiatric evaluation  1  1/54 (1.85%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  2/54 (3.70%) 
Dehydration  1  1/54 (1.85%) 
Electrolyte imbalance  1  1/54 (1.85%) 
Hypovolaemia  1  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/54 (1.85%) 
Back pain  1  1/54 (1.85%) 
Limb discomfort  1  1/54 (1.85%) 
Pain in extremity  1  1/54 (1.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Ovarian cancer  1  1/54 (1.85%) 
Nervous system disorders   
Grand mal convulsion  1  1/54 (1.85%) 
Nervous system disorder  1  1/54 (1.85%) 
Syncope  1  1/54 (1.85%) 
Renal and urinary disorders   
Hydronephrosis  1  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive airways disease exacerbated  1  1/54 (1.85%) 
Dyspnoea  1  1/54 (1.85%) 
Lung infiltration  1  1/54 (1.85%) 
Pulmonary embolism  1  1/54 (1.85%) 
Pulmonary hypertension  1  1/54 (1.85%) 
Vascular disorders   
Aortic stenosis  1  1/54 (1.85%) 
Deep vein thrombosis  1  1/54 (1.85%) 
Femoral artery occlusion  1  1/54 (1.85%) 
Peripheral occlusive disease  1  1/54 (1.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Far Only and Chemo Plus Far and Maintenance Far Only
Affected / at Risk (%)
Total   54/54 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  23/54 (42.59%) 
Neutropenia  1  23/54 (42.59%) 
Thrombocytopenia  1  20/54 (37.04%) 
Leukopenia  1  8/54 (14.81%) 
Lymphadenopathy  1  4/54 (7.41%) 
Cardiac disorders   
Tachycardia  1  3/54 (5.56%) 
Ear and labyrinth disorders   
Ear pain  1  5/54 (9.26%) 
Vertigo  1  5/54 (9.26%) 
Eye disorders   
Lacrimation increased  1  4/54 (7.41%) 
Vision blurred  1  4/54 (7.41%) 
Gastrointestinal disorders   
Nausea  1  35/54 (64.81%) 
Constipation  1  33/54 (61.11%) 
Diarrhoea  1  26/54 (48.15%) 
Vomiting  1  25/54 (46.30%) 
Abdominal Pain  1  24/54 (44.44%) 
Abdominal distension  1  13/54 (24.07%) 
Abdominal pain upper  1  8/54 (14.81%) 
Dyspepsia  1  8/54 (14.81%) 
Oral pain  1  7/54 (12.96%) 
Ascites  1  5/54 (9.26%) 
Flatulence  1  4/54 (7.41%) 
Hiatus hernia  1  4/54 (7.41%) 
Stomatitis  1  4/54 (7.41%) 
Abdominal pain lower  1  3/54 (5.56%) 
Abdominal tenderness  1  3/54 (5.56%) 
General disorders   
Fatigue  1  51/54 (94.44%) 
Pyrexia  1  22/54 (40.74%) 
Chills  1  14/54 (25.93%) 
Oedema peripheral  1  14/54 (25.93%) 
Asthenia  1  9/54 (16.67%) 
Adverse drug reaction  1  8/54 (14.81%) 
Pain  1  7/54 (12.96%) 
Chest discomfort  1  5/54 (9.26%) 
Influenza-like illness  1  4/54 (7.41%) 
Mucosal inflammation  1  4/54 (7.41%) 
Chest pain  1  3/54 (5.56%) 
Infusion site pain  1  3/54 (5.56%) 
Malaise  1  3/54 (5.56%) 
Immune system disorders   
Seasonal allergy  1  4/54 (7.41%) 
Cytokine release syndrome  1  3/54 (5.56%) 
Hypersensitivity  1  3/54 (5.56%) 
Infections and infestations   
Urinary tract infection  1  19/54 (35.19%) 
Nasopharyngitis  1  13/54 (24.07%) 
Upper respiratory tract infection  1  7/54 (12.96%) 
Bronchitis  1  6/54 (11.11%) 
Pneumonia  1  3/54 (5.56%) 
Sinusitis  1  3/54 (5.56%) 
Injury, poisoning and procedural complications   
Contusion  1  5/54 (9.26%) 
Investigations   
Weight decreased  1  6/54 (11.11%) 
White blood cell count decreased  1  4/54 (7.41%) 
Haemoglobin decreased  1  3/54 (5.56%) 
Red blood cell count decreased  1  3/54 (5.56%) 
Metabolism and nutrition disorders   
Anorexia  1  7/54 (12.96%) 
Decreased appetite  1  6/54 (11.11%) 
Hypokalaemia  1  4/54 (7.41%) 
Hypomagnesaemia  1  4/54 (7.41%) 
Dehydration  1  3/54 (5.56%) 
Hyperglycaemia  1  3/54 (5.56%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  15/54 (27.78%) 
Arthralgia  1  13/54 (24.07%) 
Pain in extremity  1  10/54 (18.52%) 
Bone pain  1  7/54 (12.96%) 
Chest wall pain  1  5/54 (9.26%) 
Myalgia  1  5/54 (9.26%) 
Muscle spasms  1  4/54 (7.41%) 
Shoulder pain  1  4/54 (7.41%) 
Musculoskeletal pain  1  3/54 (5.56%) 
Nervous system disorders   
Headache  1  27/54 (50.00%) 
Dizziness  1  11/54 (20.37%) 
Neuropathy peripheral  1  8/54 (14.81%) 
Neuropathy  1  6/54 (11.11%) 
Peripheral sensory neuropathy  1  5/54 (9.26%) 
Hypoaesthesia  1  4/54 (7.41%) 
Psychiatric disorders   
Anxiety  1  9/54 (16.67%) 
Depression  1  8/54 (14.81%) 
Insomnia  1  8/54 (14.81%) 
Renal and urinary disorders   
Haematuria  1  8/54 (14.81%) 
Dysuria  1  5/54 (9.26%) 
Urinary incontinence  1  3/54 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  20/54 (37.04%) 
Cough  1  15/54 (27.78%) 
Pharyngolaryngeal pain  1  9/54 (16.67%) 
Dyspnoea exertional  1  6/54 (11.11%) 
Atelectasis  1  4/54 (7.41%) 
Pleural effusion  1  4/54 (7.41%) 
Rhinitis allergic  1  3/54 (5.56%) 
Sinus congestion  1  3/54 (5.56%) 
Wheezing  1  3/54 (5.56%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  24/54 (44.44%) 
Rash  1  11/54 (20.37%) 
Pruritus  1  10/54 (18.52%) 
Dry skin  1  7/54 (12.96%) 
Erythema  1  5/54 (9.26%) 
Hyperhidrosis  1  5/54 (9.26%) 
Drug eruption  1  3/54 (5.56%) 
Night sweats  1  3/54 (5.56%) 
Vascular disorders   
Hypertension  1  6/54 (11.11%) 
Flushing  1  4/54 (7.41%) 
Hypotension  1  4/54 (7.41%) 
Hot flush  1  3/54 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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
Name/Title: Susan Weil, MD
Organization: Morphotek, Inc.
Phone: 610-423-6182
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00318370     History of Changes
Other Study ID Numbers: MORAb-003-002
First Submitted: April 24, 2006
First Posted: April 26, 2006
Results First Submitted: January 27, 2012
Results First Posted: February 15, 2012
Last Update Posted: September 9, 2015