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An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)

This study has been terminated.
(study did not meet pre-specified criteria for continuation following interim futility analysis)
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00738699
First received: August 18, 2008
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: December 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: MORAb-003 (farletuzumab)
Drug: 0.9% Saline
Drug: Paclitaxel

  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
No text entered.

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
MORAb-003 (Farletuzumab) Plus Paclitaxel Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Placebo (Normal Saline) Plus Paclitaxel An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

Participant Flow:   Overall Study
    MORAb-003 (Farletuzumab) Plus Paclitaxel   Placebo (Normal Saline) Plus Paclitaxel
STARTED   275   140 
Participants Not Treated   2   1 
Participants Treated   273   139 
COMPLETED   0   0 
NOT COMPLETED   275   140 
Withdrawal by Subject                5                0 
Lost to Follow-up                1                0 
Death                144                68 
Discontinuation of study by Sponsor                123                72 
Not specified                2                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.
Intent-to-Treat population included, the primary population for the evaluation of efficacy, was defined as all participant who were randomly assigned to test article, analyzed by the treatment assigned.

Reporting Groups
  Description
MORAb-003 (Farletuzumab) Plus Paclitaxel Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Placebo (Normal Saline) Plus Paclitaxel An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Total Total of all reporting groups

Baseline Measures
   MORAb-003 (Farletuzumab) Plus Paclitaxel   Placebo (Normal Saline) Plus Paclitaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 275   140   415 
Age 
[Units: Years]
Geometric Mean (Standard Deviation)
 60.9  (10.74)   61.2  (9.44)   61.0  (10.31) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      275 100.0%      140 100.0%      415 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months ]

3.  Secondary:   Best Overall Response   [ Time Frame: Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months ]

4.  Secondary:   Time to Tumor Response (TTR)   [ Time Frame: Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months ]

5.  Other Pre-specified:   Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)   [ Time Frame: Length of study ]

6.  Other Pre-specified:   Serologic Response Rate   [ Time Frame: Length of study ]


  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
This study was prematurely terminated by the sponsor following results of the preplanned futility analysis showing the study was unlikely to meet its statistically-defined coprimary endpoints.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
phone: 1-888-422-4743



Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00738699     History of Changes
Other Study ID Numbers: MORAb003-003PR
Study First Received: August 18, 2008
Results First Received: December 13, 2016
Last Updated: February 10, 2017