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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00849667
First received: February 13, 2009
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cancer
 Drug: MORAb-003 (farletuzumab)
Drug: 0.9% Saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Carboplatin
U.S. FDA Resources

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival using by RECIST [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1080
Study Start Date: March 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849667

  Show 375 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00849667     History of Changes
Other Study ID Numbers: MORAb003-004
Study First Received: February 13, 2009
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013