Trial · NCT02599324
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 | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cohorts 1 to 6 | 21 days after the initiation of therapy at the start of Cycle 1 | DLT Evaluable Population: participants from Phase 1b who completed at least 21 days of treatment with ibrutinib in combination with the relevant anticancer agent after the initiation of study treatment at the start of Cycle 1, or those who discontinued from study treatment due to a DLT event prior to completion of DLT observation period. For UC Cohorts 5 and 6, a DLT-evaluable participant had ≥ 90% compliance with ibrutinib during Cycle 1 (the first 21 days). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b/2 RP2D: Progression-Free Survival (PFS) as Assessed by Investigator in Cohorts 1 and 2 | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. | Efficacy Evaluable Population: Participants who received at least one dose of ibrutinib (at RP2D) in combination with at least one dose of the relevant companion drug and had at least one adequate post-baseline overall disease assessment per RECIST 1.1 guidelines or died prior to the first adequate post-baseline overall disease assessment. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | months | MEDIAN |
| PRIMARY | Phase 1b/2 RP2D: Overall Response Rate (ORR) as Assessed by Investigator in Cohorts 3 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b: ORR in Cohorts 1 to 6 | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | Efficacy Evaluable Population (Phase 1b): participants who received at least one dose of ibrutinib (at RP2D) in combination with at least one dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had at least one adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b: Disease Control Rate (DCR) in Cohorts 1 to 6 | Maximum time on study (Phase 1b only) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 34.2 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. | Efficacy Evaluable Population (Phase 1b): participants who received at least one dose of ibrutinib (at RP2D) in combination with at least one dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had at least one adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2 RP2D: DCR in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2 RP2D: PFS in Cohorts 3 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | months | MEDIAN |
| SECONDARY | Phase 1b/2 RP2D: ORR in Cohorts 1 and 2 | Maximum time on study for Cohort 1 (Phase 1b/2 RP2D) was 37.4 months; for Cohort 2 (Phase 1b/2 RP2D) was 44.7 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2 RP2D: Overall Survival (OS) in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. Per protocol, participants in Phase 1b receiving the Phase 2 RP2D and participants in Phase 2 RP2D were analyzed together. | months | MEDIAN |
| SECONDARY | Phase 1b/2 RP2D: Duration of Response (DOR) in Cohorts 1 to 6 | Maximum time on study (Phase 1b/2 RP2D) for Cohort 1 was 37.4 months; for Cohort 2 was 44.7 months; for Cohort 3 was 41.9 months; for Cohort 4 was 23.5 months; for Cohort 5 was 17.3 months; for Cohort 6 was 20.1 months. (Reverse Kaplan-Meier estimates) | Confirmed responders in Efficacy Evaluable Population (Phase 1b/2 RP2D): participants who received ≥ 1 dose of ibrutinib (at RP2D) in combination with ≥ 1 dose of the relevant companion drug or ibrutinib (at RP2D) for the single-agent therapy and: 1) Had measurable disease per RECIST 1.1 guidelines at baseline. 2) Had ≥ 1 adequate post-baseline overall disease assessment per RECIST 1.1 guidelines. | months | MEDIAN |
| SECONDARY | Phase 1b: Observed Maximum Concentration (Cmax) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable pharmacokinetic (PK) sample for this analysis | ng/mL | MEAN |
| SECONDARY | Phase 1b: Time to Cmax (Tmax) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | hours | MEDIAN |
| SECONDARY | Phase 1b: Time of Last Observed Concentration (Tlast) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | hours | MEDIAN |
| SECONDARY | Phase 1b: Area Under the Concentration-Time Curve From Time 0 to Hour 24 (AUC0-24h) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | ng∙h/mL | MEAN |
| SECONDARY | Phase 1b: Area Under the Concentration-Time Curve to Last Observed Time Point (AUClast) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | ng∙h/mL | MEAN |
| SECONDARY | Phase 1b: Terminal Elimination Half-Life (t1/2term) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | hours | MEAN |
| SECONDARY | Phase 1b: Terminal Elimination Rate Constant (λz) for Ibrutinib and Its Metabolite PCI-45227 in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | 1/h | MEAN |
| SECONDARY | Phase 1b: Apparent Total Clearance at Steady-State (CLss/F) for Ibrutinib in Cohorts 1 to 4 | Cycle 2 Day 1: predose, 1 h ± 15 min, 2 h ± 15 min, 4 h ± 15 min, 6 h ± 15 min postdose | Participants with an evaluable PK sample for this analysis | L/h | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02599324/outcomes