Trial · NCT02711137
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
NCT02711137, Phase 1, Phase 2, Terminated, Incyte Corporation; results first posted 2022-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies. Trials, record NCT02711137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02711137
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
- NCT number
- NCT02711137
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Solid Tumors
- Interventions
- INCB057643, Gemcitabine, Paclitaxel, Rucaparib, Abiraterone, Ruxolitinib, Azacitidine
- First posted
- 2016-03-17
- Last updated
- 2025-10-21
- Other registries' IDs
- eudract:2017-002641-29
- Results first posted
- 2022-04-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAE's). | From screening through at least 30 days after end of treatment, up to approximately 24 months | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. |
| Secondary | Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay | PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1 | An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643. |
| Secondary | Objective Response Rate (ORR) With INCB057643 in Solid Tumors | Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months | Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response \[complete response (CR) or partial response (PR)\]. |
| Secondary | Cmax: Maximum Observed Plasma Concentration of INCB057643. | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8 | Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state. |
| Secondary | Tmax: Time to Maximum Plasma Concentration of INCB057643 | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8 | Time to maximum plasma concentration of INCB057643 administered as monotherapy in fasted state |
| Secondary | AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643 | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 | Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB057643 administered as monotherapy in fasted state |
| Secondary | AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8 | Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state |
| Secondary | Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643. | C2D1 | Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fed state. |
| Secondary | Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643 | C2D1 | Time to maximum plasma concentration of INCB057643 administered as monotherapy in fed state |
| Secondary | AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy | C2D1 | Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fed state. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAE's). | From screening through at least 30 days after end of treatment, up to approximately 24 months | All participants enrolled in the study who received at least 1 dose of study drug. | Participants | NUMBER |
| SECONDARY | Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay | PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1 | %Inhibition of Total c-Myc | MEAN | |
| SECONDARY | Objective Response Rate (ORR) With INCB057643 in Solid Tumors | Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months | The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug. | Participants | NUMBER |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration of INCB057643. | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | nM | MEAN |
| SECONDARY | Tmax: Time to Maximum Plasma Concentration of INCB057643 | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | hours | MEDIAN |
| SECONDARY | AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643 | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | h*nM | MEAN |
| SECONDARY | AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy | Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | h*nM | MEAN |
| SECONDARY | Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643. | C2D1 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | nM | MEAN |
| SECONDARY | Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643 | C2D1 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | hours | MEDIAN |
| SECONDARY | AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy | C2D1 | PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed | h*nM | MEAN |
Source ClinicalTrials.gov
Results by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part1/Treatment Group A : 8mg QD INCB057643 | 4 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part1/Treatment Group A : 12mg QD INCB057643 | 5 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part1/Treatment Group A : 16mg QD INCB057643 | 8 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part1/Treatment Group B : 8mg QD INCB057643 | 7 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part1/Treatment Group B : 12mg QD INCB057643 | 5 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part1/Treatment Group C : 8mg QD INCB057643 | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort | 86 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort | 5 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAE's). | Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg | 2 | Participants |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part1/Treatment Group A : 8mg QD INCB057643 | 4 | |
| Overall Study | STARTED | Part1/Treatment Group A : 12mg QD INCB057643 | 5 | |
| Overall Study | STARTED | Part1/Treatment Group A : 16mg QD INCB057643 | 8 | |
| Overall Study | STARTED | Part1/Treatment Group B : 8mg QD INCB057643 | 7 | |
| Overall Study | STARTED | Part1/Treatment Group B : 12mg QD INCB057643 | 5 | |
| Overall Study | STARTED | Part1/Treatment Group C : 8mg QD INCB057643 | 1 | |
| Overall Study | STARTED | Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort | 86 | |
| Overall Study | STARTED | Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort | 5 | |
| Overall Study | STARTED | Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg | 1 | |
| Overall Study | STARTED | Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg | 2 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events3,598
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 distension | Gastrointestinal disorders | Part1/Treatment Group A : 8mg QD INCB057643 | 1 | 4 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Part1/Treatment Group A : 12mg QD INCB057643 | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part1/Treatment Group A : 16mg QD INCB057643 | 0 | 8 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part1/Treatment Group B : 8mg QD INCB057643 | 0 | 7 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part1/Treatment Group B : 12mg QD INCB057643 | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part1/Treatment Group C : 8mg QD INCB057643 | 0 | 1 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort | 1 | 86 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg | 0 | 1 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg | 0 | 2 | 0 |
1 to 10 of 3,598Source ClinicalTrials.gov
See all 3,598 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part1/Treatment Group A : 8mg QD INCB057643 | 2 | 4 |
| Total, all-cause mortality | Part1/Treatment Group A : 12mg QD INCB057643 | 4 | 5 |
| Total, all-cause mortality | Part1/Treatment Group A : 16mg QD INCB057643 | 5 | 8 |
| Total, all-cause mortality | Part1/Treatment Group B : 8mg QD INCB057643 | 6 | 7 |
| Total, all-cause mortality | Part1/Treatment Group B : 12mg QD INCB057643 | 4 | 5 |
| Total, all-cause mortality | Part1/Treatment Group C : 8mg QD INCB057643 | 1 | 1 |
| Total, all-cause mortality | Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort | 68 | 86 |
| Total, all-cause mortality | Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort | 3 | 5 |
| Total, all-cause mortality | Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg | 0 | 1 |
| Total, all-cause mortality | Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg | 1 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31527168 | 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.
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