Trial · NCT02289950
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer
NCT02289950, Phase 2, Completed, Eisai Inc.; results first posted 2021-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer. Trials, record NCT02289950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02289950
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer
- NCT number
- NCT02289950
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 332 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Platinum-Sensitive Ovarian Cancer in First Relapse
- Interventions
- Farletuzumab, Placebo
- First posted
- 2014-11-13
- Last updated
- 2021-09-02
- Results first posted
- 2021-09-02
Source ClinicalTrials.gov
Registered outcomes6
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 PD, or date of death, whichever occurs first up to approximately 5 years 5 months | PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | From the date of randomization until the date of death (up to approximately 5 years 5 months) | OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known to be alive. OS was analyzed using Kaplan-Meier method. |
| Secondary | Number of Participants With Best Overall Response (BOR) | From first dose of study drug (Baseline) up to approximately 5 years 5 months | BOR was defined as the best response of complete response (CR) or partial response (PR) or stable disease (SD) for greater than or equal to(\>=)6 months recorded from the start of the treatment until PD or death, whichever occurred first based on investigator assessment per RECIST v1.1. CR:disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than(\<)10 mm. PR:at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Time to Tumor Response (TTR) | From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months | TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. |
| Secondary | Duration of Response (DOR) | From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months | DOR was defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30 % decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval | From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months | Percentage of participants achieving each second platinum-free interval (\<6 months, 6-12 months, greater than \[\>\] 12-36 months, and \>36 months) stratified by first platinum-free interval (6 to 12 months and \>12 to 36 months) was reported. First platinum-free interval was defined as the date of completion of previous platinum-based chemotherapy until the date of first relapse (that is, first observation of progression). The date of first relapse was the progression date. Second platinum-free interval was defined as the date of completion of platinum-based chemotherapy (last dosing date) during the study until the date of progression or death (or censoring, if applicable). |
Source ClinicalTrials.gov
Outcomes6
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 PD, or date of death, whichever occurs first up to approximately 5 years 5 months | The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of randomization until the date of death (up to approximately 5 years 5 months) | The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system. | Months | MEDIAN |
| SECONDARY | Number of Participants With Best Overall Response (BOR) | From first dose of study drug (Baseline) up to approximately 5 years 5 months | Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Tumor Response (TTR) | From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months | Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. Here overall number of participants analyzed signifies participants who had CR or PR. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months | Tumor Response Evaluable Analysis Set included all randomized participants who received at least 1 dose of study drug and who had a baseline and at least 1 on treatment tumor assessment performed. Here overall number of participants analyzed signifies participants who had CR or PR. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval | From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months | The ITT Population (Full Analysis Set) included all randomized participants according to the assigned treatment by IRT system. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
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) | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 11.73 | 95% Confidence Interval 10.22 to 13.60 | Months | |
| Progression Free Survival (PFS) | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 10.78 | 95% Confidence Interval 9.49 to 13.17 | Months | |
| Overall Survival (OS) | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 43.07 | 95% Confidence Interval 37.13 to NA | Months | |
| Overall Survival (OS) | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 42.45 | 95% Confidence Interval 37.85 to NA | Months | |
| Number of Participants With Best Overall Response (BOR) | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | Complete Response | 24 | Participants | |
| Number of Participants With Best Overall Response (BOR) | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | Complete Response | 15 | Participants | |
| Number of Participants With Best Overall Response (BOR) | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | Partial Response | 72 | Participants | |
| Number of Participants With Best Overall Response (BOR) | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | Partial Response | 35 | Participants | |
| Number of Participants With Best Overall Response (BOR) | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | Stable Disease | 36 | Participants | |
| Number of Participants With Best Overall Response (BOR) | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | Stable Disease | 17 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 142 | |
| Overall Study | STARTED | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 72 | |
| Overall Study | Treated | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 140 | |
| Overall Study | Treated | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 71 | |
| Overall Study | COMPLETED | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 0 | |
| Overall Study | COMPLETED | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 0 | |
| Overall Study | NOT COMPLETED | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 142 | |
| Overall Study | NOT COMPLETED | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 72 |
Source ClinicalTrials.gov
Adverse events288
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 | Anaemia | Blood and lymphatic system disorders | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 76 | 141 | 208 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 36 | 70 | 121 |
| other | Neutropenia | Blood and lymphatic system disorders | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 55 | 141 | 225 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 24 | 70 | 82 |
| other | Leukopenia | Blood and lymphatic system disorders | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 21 | 141 | 74 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 7 | 70 | 20 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 42 | 141 | 109 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 19 | 70 | 86 |
| other | Abdominal discomfort | Gastrointestinal disorders | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 9 | 141 | 14 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 9 | 70 | 11 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 1 | 141 |
| Total, all-cause mortality | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 2 | 70 |
| Total, other adverse events | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 140 | 141 |
| Total, other adverse events | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 70 | 70 |
| Total, serious adverse events | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | 42 | 141 |
| Total, serious adverse events | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 18 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36758420 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD vs Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD: deaths from any cause | Trial comparisons |
| Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD vs Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02289950
GET https://conductscience.org/api/trials/v1/NCT02289950/results?page=2