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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00318370
First received: April 24, 2006
Last updated: November 5, 2013
Last verified: November 2013
Results First Received: January 27, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Interventions: Drug: Farletuzumab
Drug: Chemo Plus Far

  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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Far Only Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
Chemo Plus Far 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 Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.

Participant Flow for 3 periods

Period 1:   Period 1
    Far Only     Chemo Plus Far     Maintenance Far Only  
STARTED     28     0     0  
COMPLETED     21 [1]   0     0  
NOT COMPLETED     7     0     0  
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 2:   Period 2
    Far Only     Chemo Plus Far     Maintenance Far Only  
STARTED     0     47 [1]   0  
COMPLETED     0     36     0  
NOT COMPLETED     0     11     0  
Adverse Event                 0                 3                 0  
Lack of Efficacy                 0                 5                 0  
Physician Decision                 0                 1                 0  
Withdrawal by Subject                 0                 1                 0  
Unknown                 0                 1                 0  
[1] 26 participants enrolled directly into Chemo Plus Far plus 21 participants from Far Only.

Period 3:   Period 3
    Far Only     Chemo Plus Far     Maintenance Far Only  
STARTED     0     0     36  
COMPLETED     0     0     3  
NOT COMPLETED     0     0     33  
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  
Unknown                 0                 0                 3  



  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.
No text entered.

Reporting Groups
  Description
Far Only and Chemo Plus Far and Maintenance Far Only

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.


Baseline Measures
    Far Only and Chemo Plus Far and Maintenance Far Only  
Number of Participants  
[units: participants]
  54  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 11.66  
Gender  
[units: participants]
 
Female     54  
Male     0  
Race/Ethnicity, Customized  
[units: 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  



  Outcome Measures
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1.  Primary:   Serologic Response (Change in CA125 Level)   [ Time Frame: Baseline to response (up to 30 weeks) ]

2.  Primary:   Serologic Response (Change in Cancer Antigen [CA-125] Level)   [ Time Frame: Baseline to response (up to 27 weeks) ]

3.  Secondary:   Time to Serologic Response (Change in CA-125 Level)   [ Time Frame: Baseline to response (up to 27 weeks) ]

4.  Secondary:   Duration of Serologic Response (CA-125)   [ Time Frame: Baseline to response (up to 44 months) ]

5.  Secondary:   Overall Response Rate   [ Time Frame: Baseline to response (up to 44 months) ]

6.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Baseline to response (up to 44 months) ]

7.  Secondary:   Percentage of Participants Who Had a Prolongation of Remission   [ Time Frame: Baseline to response (up to 44 months) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Susan Weil, MD
Organization: Morphotek, Inc.
phone: 610-423-6182
e-mail: sweil@morphotek.com


No publications provided by Morphotek

Publications automatically indexed to this study:

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00318370     History of Changes
Other Study ID Numbers: MORAb-003-002
Study First Received: April 24, 2006
Results First Received: January 27, 2012
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration