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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 is a Phase 1 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 97 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02587598
The ClinicalTrials.gov registry entry for NCT02587598 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Azacitidine is the first listed.
NCT02587598 reports 0 study locations.
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.
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