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NCT02587598 · ClinicalTrials.gov registry record · Phase 1
Study of INCB053914 in Subjects With Advanced Malignancies
A Phase 1 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT02587598: Clinical Trial Phase 1 study, sponsored by Incyte Corporation.
NCT02587598 is a Phase 1 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02587598, a Phase 1 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study Summary
This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).
Interventions
- DRUG Azacitidine
- DRUG Ruxolitinib
- DRUG INCB053914
- DRUG I-DAC (Intermediate dose cytarabine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2015-12-29 |
| Est. Completion | 2020-08-11 |
| Phase | Phase 1 |
Why NCT02587598 stopped before completion
NCT02587598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 4 interventions - of which Azacitidine is the first listed.
NCT02587598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02587598 about?
NCT02587598 is a clinical study titled "Study of INCB053914 in Subjects With Advanced Malignancies". This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the...
What is the current status of trial NCT02587598?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2015-12-29. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT02587598?
The interventions under investigation include: Azacitidine (DRUG), Ruxolitinib (DRUG), INCB053914 (DRUG), I-DAC (Intermediate dose cytarabine) (DRUG).
Who is sponsoring clinical trial NCT02587598?
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 NCT02587598's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 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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