Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
Public ClinicalTrials.gov record NCT02711137. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.
Study identification
- NCT ID
- NCT02711137
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 137 participants
Conditions and interventions
Conditions
Interventions
- INCB057643 Drug
- Gemcitabine Drug
- Paclitaxel Drug
- Rucaparib Drug
- Abiraterone Drug
- Ruxolitinib Drug
- Azacitidine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2016 (Actual)
- Primary completion
- Feb 13, 2019 (Actual)
- Completion
- Feb 13, 2019 (Actual)
- Last update posted
- Oct 21, 2025
2016 – 2019
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-3300 | — |
| University of California | La Jolla | California | 92093 | — |
| Sarah Cannon Research Institute at Health One | Denver | Colorado | 80218 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Hematology - Oncology Associates of Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University of Rochester, Wilmot Cancer Center | Rochester | New York | 14642 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Oncology Consultants, P.A. | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02711137, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 21, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02711137 live on ClinicalTrials.gov.