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Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00849667
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Morphotek

Brief Summary:
This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: MORAb-003 (farletuzumab) Drug: 0.9% Saline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Study Start Date : April 2009
Primary Completion Date : December 2012
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Carboplatin and taxane with MORAb-003 1.25 mg/kg
Drug: MORAb-003 (farletuzumab)
MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
Active Comparator: 2
Carboplatin and taxane with MORAb-003 2.5 mg/kg
Drug: MORAb-003 (farletuzumab)
MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
Placebo Comparator: 3
Carboplatin and taxane with Placebo
Drug: 0.9% Saline
0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.



Primary Outcome Measures :
  1. Progression-free survival using by RECIST [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
  • Must have measurable disease by CT or MRI scan
  • Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy
  • Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
  • Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
  • Must be a candidate for carboplatin and taxane therapy
  • Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Exclusion Criteria:

  • Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
  • Subjects who have received other therapy to treat their ovarian cancer since relapse
  • Known central nervous system (CNS) tumor involvement
  • Evidence of other active invasive malignancy requiring treatment in the past 5 years
  • Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
  • Previous treatment with MORAb-003 (farletuzumab)
  • Clinical contraindications to use of a taxane

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849667


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Sponsors and Collaborators
Morphotek

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00849667     History of Changes
Other Study ID Numbers: MORAb003-004
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: November 2013

Keywords provided by Morphotek:
ovarian cancer
relapsed ovarian cancer
Platinum-sensitive Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immune System Diseases
Taxane
Carboplatin
Antineoplastic Agents