Trial · NCT02290431
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate | after 24 weeks (8 cycles; cycle = 21 days) | Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | 24 weeks (8 cycles; cycle = 21 days) | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | up to 30 days after end of study, approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Minimal Response Rate (MRR) Per Investigator | after 24 weeks (8 cycles; cycle = 21 days) | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | Percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) Per Investigator | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Time to Progression/Relapse (TTP) Per Investigator | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per Investigator | duration of study up to approx. 4 years | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | months | MEDIAN |
| SECONDARY | Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156 | FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component. | scores on a scale | MEDIAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | h.ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | hour (h) | MEDIAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2 | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | hour (h) | GEOMETRIC_MEAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | 1/hour (1/h) | GEOMETRIC_MEAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Litre/hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F | Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose | PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ. | Litre (L) | GEOMETRIC_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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GET https://conductscience.org/api/trials/v1/NCT02290431/outcomes