Ovarian CancerPhase 2FAR-122NCT00738699
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
A Phase 2 study testing MORAb-003 (farletuzumab), 0.9% Saline and Paclitaxel in people with Ovarian Cancer, run by Morphotek at 61 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- MORAb-003 (farletuzumab), 0.9% Saline and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 61 sitesin 6 countries
- Study dates
- Sep 2008to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
61 sites in 6 countries.
61 sites in 6 countries
United States34 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, 22003
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237
Schwartz Gynecologic Oncology, PLLC
Brightwaters, New York, 11718
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
California Cancer Care, Inc.
Greenbrae, California, 94904
International Beneficence Clinical Research, LLC
Harlingen, Texas, 78550
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, 46260
Jupiter Medical Center
Jupiter, Florida, 33458
Moores UC San Diego Cancer Center
La Jolla, California, 92093
Arena Oncology Associates, PC
Lake Success, New York, 11042
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, 70006
Innovative Medical Research of South Florida, Inc.
Miami, Florida, 33179
Signal Point Clinical Research Center
Middletown, Ohio, 45042
Southern Cancer Center
Mobile, Alabama, 36608
Monterey Bay Oncology
Monterey, California, 93940
Morristown Memorial Hospital
Morristown, New Jersey, 07962
St. Luke's Roosevelt Hospital Center
New York, New York, 10019
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Florida Hospital Cancer Institute
Orlando, Florida, 32804
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Utah Cancer Specialists
Salt Lake City, Utah, 84106
South Texas Oncology & Hematology PA
San Antonio, Texas, 78229
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Memorial Health University Medical Center
Savannah, Georgia, 31404
Scott & White Memorial Hospital and Clinic
Temple, Texas, 76508
Cancer Care Associates
Tulsa, Oklahoma, 74136
Central DuPage Hospital
Winfield, Illinois, 60190
Piedmont Hematology Oncology Associates, PA
Winston-Salem, North Carolina, 27103
Australia9 sites
Monash Medical Centre
East Bentleigh, Victoria, 3165
Mercy Hospital for Women
Heidelburg, Victoria, 3084
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
The Royal Women's Hospital
Parkville, Victoria, 3052
Prince of Wales Hospital
Randwick, New South Wales, 2031
St. John of God Hospital
Subiaco, Western Australia, 6008
The Burnside War Memorial Hospital, Inc.
Toorak Gardens, South Australia, 5064
Westmead Hospital
Westmead, New South Wales, 2145
Spain8 sites
Fundacion Hospital Alcorcon
Alcorcón, Madrid, 28922
Hospital Clinic I Provincial
Barcelona, Barcelona, 08036
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital de Mataro
Mataró, Barcelona, 08304
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07014
Hospital de Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Corporacio Sanitaria Parc Taulis
Sabadell, Barcelona, 08208
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
BC Cancer Agency
Kelowna, British Columbia, V1Y5L3
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Belgium3 sites
AZ Greninge Hospital
Kortrijk
University Hospitals Leuven
Leuven
CHU de Liege
Liège
Netherlands3 sites
UMCG
Groningen, 9700 RB
University Hospital Maastricht
Maastricht, 6229 HX
UMC Utrecht
Utrecht, 3584 CX
About this study
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
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
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- MORAb-003 (farletuzumab), 0.9% Saline, Paclitaxel
- Keywords
- ovarian cancer, relapsed ovarian cancer, refractory ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-003 (farletuzumab)Drug
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.
0.9% SalineDrug
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.
PaclitaxelDrug
Also called Paclitaxel (80 mg/m^2) was administered by IV infusion over 1 hour following administration of FAR.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MORAb-003 (Farletuzumab) Plus Paclitaxel Receives: Drug: MORAb-003 (farletuzumab); Drug: Paclitaxel |
| 2 | Placebo comparator | Placebo Plus Paclitaxel Receives: Drug: 0.9% Saline; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Secondary outcomes (2)
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).
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2011
- Study completionJan 2012
Why it stopped: study did not meet pre-specified criteria for continuation following interim futility analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738699
- Sponsor's protocol ID
- MORAb003-003PR
- Acronym
- FAR-122
- Status last verified
- Feb 2017
- First submitted
- 18 Aug 2008
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00738699
- Acronym / sponsor ID
- FAR-122 / MORAb003-003PR
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, relapsed ovarian cancer, refractory ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study did not meet pre-specified criteria for continuation following interim futility analysis
- Enrolment
- 415 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MORAb-003 (farletuzumab), Drug: PaclitaxelMORAb-003 (Farletuzumab) Plus Paclitaxel |
| 2 | Placebo comparator | Drug: 0.9% Saline, Drug: PaclitaxelPlacebo Plus Paclitaxel |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Clinical contraindications to use of paclitaxel, which include:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORAb-003 (farletuzumab)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. | Drug | 1 |
| 0.9% SalinePlacebo (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. | Drug | 2 |
| PaclitaxelAlso: Paclitaxel (80 mg/m^2) was administered by IV infusion over 1 hour following administration of FAR. | Drug | 1, 2 |
Primary outcome
Progression-Free Survival (PFS)
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
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)
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
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.
2 secondary outcomes
Best Overall Response
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
Time to Tumor Response (TTR)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORAb-003 (farletuzumab), 0.9% Saline and Paclitaxel in people with Ovarian Cancer, run by Morphotek at 61 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Australia, Spain, Canada, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.