Trial · NCT02654990
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 168 days | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | ORR Throughout the Study | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | iCR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | sCR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | CR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | VGPR Rate | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Maximum Plasma Concentration (Cmax): Panobinostat | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | ng/mL | MEAN |
| SECONDARY | Cmax: Bortezomib | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | ng/mL | MEAN |
| SECONDARY | Time to Reach Cmax (Tmax): Panobinostat | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of panobinostat after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | hours | MEAN |
| SECONDARY | Tmax: Bortezomib | Cycle 1 Day 1 (Pre-dose, up to 8 hours post dose) | Pharmacokinetics Analysis Set (PAS): all participants with at least 1 evaluable pharmacokinetics concentration of bortezomib after dosing on Day 1. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | hours | MEAN |
| SECONDARY | Exposure Response: Cmax for Panobinostat | Up to 5.2 Years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | percent probability | NUMBER |
| SECONDARY | Change From Baseline in European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Core 30-item Questionnaire (QLQ-C30) Global Health Status (GHS) Score | Cycle 15 Day 1, at approximately 295 days | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group-Neurotoxicity (GOG-Ntx) Neurotoxicity Subscale Score | Cycle 15 Day 1, at approximately 295 days | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed. | score on a scale | MEAN |
| SECONDARY | Time to Progression (TTP) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Up to 5.2 years | Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. | months | MEDIAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02654990/outcomes