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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORAb-003 (farletuzumab)
0.9% Saline
Paclitaxel
Sponsored by
Morphotek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, relapsed ovarian cancer, refractory ovarian cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Southern Cancer Center
  • St. Joseph's Hospital and Medical Center
  • California Cancer Care, Inc.
  • Moores UC San Diego Cancer Center
  • USC/Norris Comprehensive Cancer Center
  • Monterey Bay Oncology
  • Jupiter Medical Center
  • Innovative Medical Research of South Florida, Inc.
  • Florida Hospital Cancer Institute
  • Sarasota Memorial Hospital
  • Memorial Health University Medical Center
  • Central DuPage Hospital
  • St. Vincent Gynecologic Oncology
  • Hematology and Oncology Specialists, LLC
  • Johns Hopkins Hospital
  • Weinberg Cancer Institute at Franklin Square
  • Henry Ford Health System
  • Morristown Memorial Hospital
  • Schwartz Gynecologic Oncology, PLLC
  • Arena Oncology Associates, PC
  • St. Luke's Roosevelt Hospital Center
  • Memorial Sloan-Kettering Cancer Center
  • Piedmont Hematology Oncology Associates, PA
  • Cleveland Clinic
  • Signal Point Clinical Research Center
  • Cancer Care Associates
  • Abington Memorial Hospital
  • Magee-Women's Hospital of UPMC
  • Medical University of South Carolina
  • International Beneficence Clinical Research, LLC
  • South Texas Oncology & Hematology PA
  • Scott & White Memorial Hospital and Clinic
  • Utah Cancer Specialists
  • Northern Virginia Pelvic Surgery Associates
  • Prince of Wales Hospital
  • Westmead Hospital
  • Royal Brisbane & Women's Hospital
  • The Burnside War Memorial Hospital, Inc.
  • Monash Medical Centre
  • Mercy Hospital for Women
  • The Royal Women's Hospital
  • Sir Charles Gairdner Hospital
  • St. John of God Hospital
  • AZ Greninge Hospital
  • University Hospitals Leuven
  • CHU de Liege
  • Tom Baker Cancer Centre
  • BC Cancer Agency
  • Juravinski Cancer Centre
  • Sunnybrook Health Sciences Centre
  • UMCG
  • University Hospital Maastricht
  • UMC Utrecht
  • Hospital Universitario Son Dureta
  • Hospital de Son Llatzer
  • Hospital de Mataro
  • Corporacio Sanitaria Parc Taulis
  • Consorci Sanitari de Terrassa
  • Fundacion Hospital Alcorcon
  • Hospital Clinic I Provincial
  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

MORAb-003 (Farletuzumab) Plus Paclitaxel

Placebo Plus Paclitaxel

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.

Secondary Outcome Measures

Best Overall Response
BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
Time to Tumor Response (TTR)
TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.

Full Information

First Posted
August 18, 2008
Last Updated
February 10, 2017
Sponsor
Morphotek
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1. Study Identification

Unique Protocol Identification Number
NCT00738699
Brief Title
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
study did not meet pre-specified criteria for continuation following interim futility analysis
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, relapsed ovarian cancer, refractory ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
MORAb-003 (Farletuzumab) Plus Paclitaxel
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo Plus Paclitaxel
Intervention Type
Drug
Intervention Name(s)
MORAb-003 (farletuzumab)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9% Saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Paclitaxel (80 mg/m^2) was administered by IV infusion over 1 hour following administration of FAR.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
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
Title
Overall Survival (OS)
Description
OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
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
Secondary Outcome Measure Information:
Title
Best Overall Response
Description
BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
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
Title
Time to Tumor Response (TTR)
Description
TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
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
Other Pre-specified Outcome Measures:
Title
Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)
Description
Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
Time Frame
Length of study
Title
Serologic Response Rate
Description
Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.
Time Frame
Length of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: persistent Grade 2 or greater peripheral neuropathy 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).
Facility Information:
Facility Name
Southern Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Moores UC San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Monterey Bay Oncology
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
St. Vincent Gynecologic Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Hematology and Oncology Specialists, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Weinberg Cancer Institute at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Schwartz Gynecologic Oncology, PLLC
City
Brightwaters
State/Province
New York
ZIP/Postal Code
11718
Country
United States
Facility Name
Arena Oncology Associates, PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Piedmont Hematology Oncology Associates, PA
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Magee-Women's Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
International Beneficence Clinical Research, LLC
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
South Texas Oncology & Hematology PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott & White Memorial Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Northern Virginia Pelvic Surgery Associates
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
The Burnside War Memorial Hospital, Inc.
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5064
Country
Australia
Facility Name
Monash Medical Centre
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Mercy Hospital for Women
City
Heidelburg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Royal Women's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
St. John of God Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
AZ Greninge Hospital
City
Kortrijk
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
CHU de Liege
City
Liege
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer Agency
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y5L3
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Universitario Son Dureta
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital de Son Llatzer
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital de Mataro
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
Corporacio Sanitaria Parc Taulis
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Fundacion Hospital Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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