Trial · NCT03314935
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
NCT03314935, Phase 1, Phase 2, Completed, Incyte Corporation; results first posted 2023-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors. Trials, record NCT03314935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03314935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
- NCT number
- NCT03314935
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 149 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
- Interventions
- INCB001158, Oxaliplatin, Leucovorin, 5-Fluorouracil, Gemcitabine, Cisplatin, Paclitaxel
- First posted
- 2017-10-19
- Last updated
- 2025-08-12
- Other registries' IDs
- eudract:2017-002904-29
- Results first posted
- 2023-12-07
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 1385 days | 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. |
| Primary | Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT) | up to Day 28 | 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. |
| Primary | Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen | up to Day 580 | 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. |
| Primary | Phase 2: Objective Response Rate (ORR) | up to 1385 days | 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. |
| Secondary | Phase 1: ORR | up to 580 days | 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. |
| Secondary | Phases 1 and 2: Duration of Response | up to 368 days | 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. |
| Secondary | Phases 1 and 2: Disease Control Rate | up to 1385 days | 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. |
| Secondary | Phases 1 and 2: Progression-free Survival | up to 1385 days | 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. |
| 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 | 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. |
| 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 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group119
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | 8 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | 6 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | 13 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | 7 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | 4 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | 46 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | 7 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | 5 | Participants | ||
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel | 51 | Participants | ||
| Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT) | Phase 1: INCB001158 50 mg + mFOLFOX6 | 0 | Participants |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Phase 1: INCB001158 50 mg + mFOLFOX6 | 8 | |
| Phase 1 | STARTED | Phase 1: INCB001158 75 mg + mFOLFOX6 | 6 | |
| Phase 1 | STARTED | Phase 1: INCB001158 100 mg + mFOLFOX6 | 6 | |
| Phase 1 | STARTED | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | 7 | |
| Phase 1 | STARTED | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | 4 | |
| Phase 1 | STARTED | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | 4 | |
| Phase 1 | STARTED | Phase 1: INCB001158 50 mg + Paclitaxel | 7 | |
| Phase 1 | STARTED | Phase 1: INCB001158 75 mg + Paclitaxel | 5 | |
| Phase 1 | STARTED | Phase 1: INCB001158 100 mg + Paclitaxel | 7 | |
| Phase 1 | STARTED | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events2,960
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | 0 | 8 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | 1 | 6 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | 0 | 14 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | 0 | 7 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | 2 | 46 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | 0 | 7 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | 0 | 5 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel | 2 | 52 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Total | 5 | 149 | 5 |
1 to 10 of 2,960Source ClinicalTrials.gov
See all 2,960 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | 4 | 8 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | 2 | 6 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | 11 | 14 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | 4 | 7 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | 3 | 4 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | 30 | 46 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | 5 | 7 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | 4 | 5 |
| Total, all-cause mortality | Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel | 36 | 52 |
| Total, all-cause mortality | Total | 99 | 149 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39462179 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
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