Trial · NCT00849667
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
NCT00849667, Phase 3, Terminated, Morphotek; results first posted 2022-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse. Trials, record NCT00849667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00849667
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
- NCT number
- NCT00849667
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,100 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Ovarian Cancer
- Interventions
- Farletuzumab, Carboplatin, Taxane, Farletuzumab-matched placebo
- First posted
- 2009-02-24
- Last updated
- 2022-12-30
- Other registries' IDs
- eudract:2008-005872-29
- Results first posted
- 2022-12-30
- Limitations and caveats
Study termination was based on the primary analysis results for progression-free survival (PFS). Data collection and analyses of health care resource utilization were not performed due to the study being terminated early. Pharmacokinetic data was collected and analyzed for a maximum of only 7 participants in this study.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) | PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \[RECIST\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, 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). |
| Secondary | Overall Survival (OS) | From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months) | OS was defined as the time (in months) from the date of randomization to the date of death, due to any 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 | Cancer Antigen-125 (CA-125) Progression-Free Survival | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) | CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (\>=) 2 multiple (\*) ULN with either event documented on two occasions or CA-125 \>=2\*nadir value with either event documented on two occasions. |
| Secondary | Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) | PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 \>=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 \>=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 \>=two times ULN on two occasions at least one week apart. |
| Secondary | Percentage of Participants With Length of Second Remission Greater Than First Remission | From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months) | Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. |
| Secondary | Percentage of Participants With Objective Response | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months) | Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Tumor Response | From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months) | Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR. |
| Secondary | Time to Tumor Response (TTR) | From the date of randomization to first documentation of objective response (up to 48 months) | Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR. |
| Secondary | Percentage of Participants With Serologic Response (SR) | Up to 48 months | SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample. |
| Secondary | Duration of 50% Serologic Response | From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months) | Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months) | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | months | MEDIAN |
| SECONDARY | Cancer Antigen-125 (CA-125) Progression-Free Survival | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | months | MEDIAN |
| SECONDARY | Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Length of Second Remission Greater Than First Remission | From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months) | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. Here N overall number of participants analyzed included all participants with potential for second remission greater than first remission. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months) | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | percentage of participants | NUMBER |
| SECONDARY | Duration of Tumor Response | From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months) | Analysis performed on a subset of participants who had objective response. | months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | From the date of randomization to first documentation of objective response (up to 48 months) | Analysis performed on a subset of participants who had objective response. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Serologic Response (SR) | Up to 48 months | SR Evaluable Populations included all randomized participants who received at least one dose of study drug and who had a baseline and at least one assessment during treatment, sufficient to assess the endpoint of interest. | percentage of participants | NUMBER |
| SECONDARY | Duration of 50% Serologic Response | From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months) | Analysis was performed on a subset of participants who had serologic response. | months | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 9.5 | 95% Confidence Interval 8.6 to 10.2 | months | |
| Progression-free Survival (PFS) | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 9.7 | 95% Confidence Interval 8.8 to 10.4 | months | |
| Progression-free Survival (PFS) | Placebo Plus Taxane and Carboplatin | 9.0 | 95% Confidence Interval 8.4 to 9.8 | months | |
| Overall Survival (OS) | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 28.7 | 95% Confidence Interval 26.6 to 33.5 | months | |
| Overall Survival (OS) | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 32.1 | 95% Confidence Interval 26.7 to 35.0 | months | |
| Overall Survival (OS) | Placebo Plus Taxane and Carboplatin | 29.1 | 95% Confidence Interval 25.6 to 30.7 | months | |
| Cancer Antigen-125 (CA-125) Progression-Free Survival | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 13.2 | 95% Confidence Interval 11.8 to 14.4 | months | |
| Cancer Antigen-125 (CA-125) Progression-Free Survival | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 18.1 | 95% Confidence Interval 12.7 to NA | months | |
| Cancer Antigen-125 (CA-125) Progression-Free Survival | Placebo Plus Taxane and Carboplatin | 12.0 | 95% Confidence Interval 11.1 to 14.6 | months | |
| Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 8.8 | 95% Confidence Interval 8.4 to 9.7 | months |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 370 | |
| Overall Study | STARTED | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 366 | |
| Overall Study | STARTED | Placebo Plus Taxane and Carboplatin | 364 | |
| Overall Study | Safety Analysis Set | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 376 | |
| Overall Study | Safety Analysis Set | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 363 | |
| Overall Study | Safety Analysis Set | Placebo Plus Taxane and Carboplatin | 352 | |
| Overall Study | COMPLETED | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 0 | |
| Overall Study | COMPLETED | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 0 | |
| Overall Study | COMPLETED | Placebo Plus Taxane and Carboplatin | 0 | |
| Overall Study | NOT COMPLETED | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 370 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events879
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 215 | 376 | 486 |
| other | Nausea | Gastrointestinal disorders | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 185 | 363 | 395 |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Taxane and Carboplatin | 188 | 352 | 459 |
| other | Diarrhoea | Gastrointestinal disorders | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 134 | 376 | 251 |
| other | Diarrhoea | Gastrointestinal disorders | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 125 | 363 | 207 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Taxane and Carboplatin | 126 | 352 | 262 |
| other | Vomiting | Gastrointestinal disorders | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 129 | 376 | 224 |
| other | Vomiting | Gastrointestinal disorders | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 110 | 363 | 167 |
| other | Vomiting | Gastrointestinal disorders | Placebo Plus Taxane and Carboplatin | 103 | 352 | 211 |
| other | Constipation | Gastrointestinal disorders | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 119 | 376 | 167 |
1 to 10 of 879Source ClinicalTrials.gov
See all 879 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 143 | 376 |
| Total, all-cause mortality | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 119 | 363 |
| Total, all-cause mortality | Placebo Plus Taxane and Carboplatin | 121 | 352 |
| Total, other adverse events | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 373 | 376 |
| Total, other adverse events | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 358 | 363 |
| Total, other adverse events | Placebo Plus Taxane and Carboplatin | 347 | 352 |
| Total, serious adverse events | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | 140 | 376 |
| Total, serious adverse events | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | 130 | 363 |
| Total, serious adverse events | Placebo Plus Taxane and Carboplatin | 112 | 352 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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