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

Sponsor:	Morphotek
Information provided by:	Morphotek
ClinicalTrials.gov Identifier:	NCT00849667

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Ovarian Cancer

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:	900
Study Start Date:	March 2009
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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, i.e. on Day1 and week1 of each 21-day cycle.
2: Active Comparator Carboplatin and taxane with MORAb-003 2.5 mg/kg	Drug: MORAb-003 (farletuzumab) MORAb-003 2.5mg/kg infusions will take place weekly, i.e. on Day1 and week1 of each 21-day cycle.
3: Placebo Comparator Carboplatin and taxane with Placebo	Drug: 0.9% Saline 0.9% infusions will take place weekly, i.e. on Day1 and week1 of each 21-day cycle

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 within ≥6 and < 24 months of completion of first-line platinum/taxane chemotherapy
Must be a candidate for repeat carboplatin/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

Contacts

Contact: Susan C Weil, MD, FACP

610-423-6182

weil@morphotek.com

Show 129 Study Locations

Sponsors and Collaborators

Morphotek

More Information

No publications provided

Responsible Party:	Morphotek, Inc ( Susan Weil, M.D. /Study Medical Monitor )
Study ID Numbers:	MORAb003-004
Study First Received:	February 13, 2009
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00849667 History of Changes
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:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009