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

Ovarian Cancer Clinical Trial

— FAR-122  

Official title:

A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab) in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00738699
• Other study ID #: MORAb003-003PR
• Status: Terminated
• Phase: Phase 2
• First received: August 18, 2008
• Last updated: April 24, 2015
• Start date: September 2008
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003(farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 412
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry

• Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.

• Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;

• Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.

• Subjects must be candidate for repeat paclitaxel treatment

Exclusion Criteria:

• Clinical contraindications to use of paclitaxel, which include:

1. persistent Grade 2 or greater peripheral neuropathy

2. prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation

• Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did

• Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal

• Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).

• Previous treatment with MORAb-003 (farletuzumab).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• MORAb-003 (farletuzumab)
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
• 0.9% Saline
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles

Locations

Country	Name	City	State
Australia	Monash Medical Centre	East Bentleigh	Victoria
Australia	Mercy Hospital for Women	Heidelburg	Victoria
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	The Royal Women's Hospital	Parkville	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	St. John of God Hospital	Subiaco	Western Australia
Australia	The Burnside War Memorial Hospital, Inc.	Toorak Gardens	South Australia
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	AZ Greninge Hospital	Kortrijk
Belgium	University Hospitals Leuven	Leuven
Belgium	CHU de Liege	Liege
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	BC Cancer Agency	Kelowna	British Columbia
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Netherlands	UMCG	Groningen
Netherlands	University Hospital Maastricht	Maastricht
Netherlands	UMC Utrecht	Utrecht
Spain	Fundacion Hospital Alcorcon	Alcorcon	Madrid
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital de Mataro	Mataro	Barcelona
Spain	Hospital de Son Llatzer	Palma de Mallorca	Baleares
Spain	Hospital Universitario Son Dureta	Palma de Mallorca	Baleares
Spain	Corporacio Sanitaria Parc Taulis	Sabadell	Barcelona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Northern Virginia Pelvic Surgery Associates	Annandale	Virginia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Weinberg Cancer Institute at Franklin Square	Baltimore	Maryland
United States	Schwartz Gynecologic Oncology, PLLC	Brightwaters	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	California Cancer Care, Inc.	Greenbrae	California
United States	International Beneficence Clinical Research, LLC	Harlingen	Texas
United States	St. Vincent Gynecologic Oncology	Indianapolis	Indiana
United States	Jupiter Medical Center	Jupiter	Florida
United States	Moores UC San Diego Cancer Center	La Jolla	California
United States	Arena Oncology Associates, PC	Lake Success	New York
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Hematology and Oncology Specialists, LLC	Metairie	Louisiana
United States	Innovative Medical Research of South Florida, Inc.	Miami	Florida
United States	Signal Point Clinical Research Center	Middletown	Ohio
United States	Southern Cancer Center	Mobile	Alabama
United States	Monterey Bay Oncology	Monterey	California
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	South Texas Oncology & Hematology PA	San Antonio	Texas
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Scott & White Memorial Hospital and Clinic	Temple	Texas
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	Central DuPage Hospital	Winfield	Illinois
United States	Piedmont Hematology Oncology Associates, PA	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) as determined by RECIST	PFS as determined by RECIST	Length of Study	No
Primary	Overall Survival		Length of study	No
Secondary	Progression Free Survival based on Gynecologic Cancer InterGroup(GCIG)	PFS as assessed byt CGIG criteria	Length of study	No
Secondary	Overall Response Rate		Length of study	No
Secondary	Serologic response rate	Serologic response rate assessed by modified Rustin Criteria	Length of study	No
Secondary	Safety and tolerability	Assessed by safety measurements such as review of Adverse events, Vital signs, Physical exams, Electrocardiograms, Clinical labrotory tests, Karnofsky's performance status.	Length of Study	Yes