Trial · NCT03314935
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 1385 days | Full Analysis Set (FAS): all participants enrolled in the study who received at least 1 dose of INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel. As pre-defined in the Statistical Analysis Plan, data analysis was conducted based on treatment group and dose level, regardless of study phase, because the safety profile was expected to be generally uniform across tumor types. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT) | up to Day 28 | Phase 1 DLT Evaluable Population: all participants enrolled in Phase 1 who had been treated with the assigned dose level of INCB001158 and who had received at least 32 of the 42 doses prescribed for a 21-day cycle regimen or at least 42 of the 56 doses prescribed for a 28-day cycle regimen (both representing ≥ 75% of the dose planned) or who had experienced a DLT | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen | up to Day 580 | DLT Evaluable Population | milligrams | NUMBER |
| PRIMARY | Phase 2: Objective Response Rate (ORR) | up to 1385 days | Phase 2 Response Evaluable Population: all participants who had received ≥1 dose of study treatment (INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel), completed a Baseline scan, and met ≥1 of the following criteria: (a) had ≥1 post-Baseline scan; (b) was in the study for a minimum of 63 days (8 weeks + 1 week window) of follow-up; (c) discontinued from study treatment | percentage of participants | NUMBER |
| SECONDARY | Phase 1: ORR | up to 580 days | Phase 1 Response Evaluable Population: all participants who had received ≥1 dose of study treatment (INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel), completed a Baseline scan, and met ≥1 of the following criteria: (a) had ≥1 post-Baseline scan; (b) was in the study for a minimum of 63 days (8 weeks + 1 week window) of follow-up; (c) discontinued from study treatment. Analysis was conducted by dose. | percentage of participants | NUMBER |
| SECONDARY | Phases 1 and 2: Duration of Response | up to 368 days | Response Evaluable Population. Analysis was conducted based on study phase. Analysis was conducted by dose in Phase 1 and by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates. Analysis was conducted in cohorts with \>5 objective responders; the Kaplan Meier estimation method on a sample size of \<5 responders is not valid. The confidence interval was calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Phases 1 and 2: Disease Control Rate | up to 1385 days | Response Evaluable Population. Data analysis was conducted based on study phase. Additionally, analysis was conducted by dose in Phase 1 and by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates. | percentage of participants | NUMBER |
| SECONDARY | Phases 1 and 2: Progression-free Survival | up to 1385 days | FAS. Data analysis was conducted based on study phase. Additionally, analysis was conducted by dose in Phase 1 and by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates. Median survival time was estimated using the Kaplan-Meier method. CI for median survival time was calculated using the method of Brookmeyer and Crowley. | months | MEDIAN |
| SECONDARY | Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration | Day 1 of Cycle 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycle 2: predose; 1 and 4 hours post-dose for sparse sample collection | Phase 2 Pharmacokinetic (PK) Population. Only participants with available data were analyzed. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration | Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection | Phase 2 PK Population. Only participants with available data were analyzed. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration | Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection | Phase 2 PK Population. Only participants with available data were analyzed. | hours | MEDIAN |
| SECONDARY | AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration | Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection | Phase 2 PK Population. Only participants with available data were analyzed. | hours x ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration | Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection | Phase 2 PK Population. Only participants with available data were analyzed. | hours | 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.
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