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Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.

INCB001158

Oxaliplatin administered intravenously at the protocol-defined dose and schedule.

Leucovorin at the protocol-defined dose and regimen.

5-Fluorouracil at the protocol-defined dose and regimen.

5-Fluorouracil

Gemcitabine at the protocol-defined dose and regimen.

Cisplatin at the protocol-defined dose and regimen.

Paclitaxel at the protocol-defined dose and regimen.

Lance Leopold, MD

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.

The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.

ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions.

DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.

Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

Incyte Corporation

Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. 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.

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or solid metastatic tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6

In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin

In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with BTC or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. In Phase 1, participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel

In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and GC, EC, or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel

Total

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \[m\^2\], leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1: INCB001158 50 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1: INCB001158 75 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cyce after administration of INCB001158.

Phase 1: INCB001158 100 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle.

Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle.

Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle.

Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1: INCB001158 50 mg + Paclitaxel

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1: INCB001158 75 mg + Paclitaxel

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1: INCB001158 100 mg + Paclitaxel

In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)

In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)

In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)

In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)

In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)

In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black/African-American

Asian

American-Indian/Alaska Native

East Indian

Not Provided/Specified

Black/Carribean

Captured as Hispanic/Latino in Database

Race/Ethnicity, Customized

Study Director

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.

Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

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

Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50, 75, or 100 mg BID plus intravenous modified FOLFOX6, intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2, or intravenous paclitaxel 80 mg/m\^2.

All Phase 1 Participants

Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen

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

Phase 2: Objective Response Rate (ORR)

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.

Phase 1: ORR

In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158

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.

Phases 1 and 2: Duration of Response

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.

Phases 1 and 2: Disease Control Rate

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.

Phases 1 and 2: Progression-free Survival

Phase 2 Pharmacokinetic (PK) Population. Only participants with available data were analyzed.

Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration

Cycle 1 Day 1

Cycle 2 Day 1

Phase 2 PK Population. Only participants with available data were analyzed.

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

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

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

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

Spots Global Cancer Trial Database for A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Trial Identification

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Study Description

Keywords

Eligibility

Locations

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