Trial · NCT00849667
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| SECONDARY | Time to 50% Serologic Response (TSR) | From the date of randomization to first documentation of 50% SR (up to 48 months) | Analysis was performed on a subset of participants who had serologic response. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Clinical Benefit | 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 | Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. | hours | MEDIAN |
| SECONDARY | AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. Here number of participants analyzed signifies participants who were analyzed for this outcome measure for given categories. | microgram hour per liter (mcg*h/L) | MEAN |
| SECONDARY | T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. Here number of participants analyzed signifies participants who were analyzed for this outcome measure for given categories. | hours | MEAN |
| SECONDARY | CL: Clearance of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. Here number of participants analyzed signifies participants who were analyzed for this outcome measure for given categories. | liter per hour (L/h) | MEAN |
| SECONDARY | Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. Here number of participants analyzed signifies participants who were analyzed for this outcome measure for given categories. | liter | MEAN |
| SECONDARY | Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores | Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days) | The population comprised of all evaluable participants who received at least one dose of farletuzumab or placebo, with study treatment assignment designated according to the IWRS/IVRS, and who completed a baseline FACT-O assessment and at least one follow-up FACT-O assessment during the study. Here overall number of participants analyzed signifies participants who were analyzed for this outcome measure. | score on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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