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NCT02711137 · ClinicalTrials.gov registry record · Phase 1
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
A Phase 1 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
NCT02711137: Clinical Trial Phase 1 study, sponsored by Incyte Corporation.
NCT02711137 is a Phase 1 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 137 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02711137, a Phase 1 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Interventions
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Abiraterone
- DRUG Rucaparib
- DRUG INCB057643
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2016-05-18 |
| Est. Completion | 2019-02-13 |
| Phase | Phase 1 |
Why NCT02711137 stopped before completion
NCT02711137 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher).
The record links to 0 conditions, and to 5 interventions - of which Paclitaxel is the first listed.
NCT02711137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02711137 about?
NCT02711137 is a clinical study titled "Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies". 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 ...
What is the current status of trial NCT02711137?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2016-05-18. Estimated completion is 2019-02-13.
What interventions are being tested in trial NCT02711137?
The interventions under investigation include: Paclitaxel (DRUG), Gemcitabine (DRUG), Abiraterone (DRUG), Rucaparib (DRUG), INCB057643 (DRUG).
Who is sponsoring clinical trial NCT02711137?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02711137's enrollment target sits among peer trials
137 420th of 2000 higher than 1,579 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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