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NCT00827138 · ClinicalTrials.gov registry record · Phase 1
Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation)
A Phase 1 study, sponsored by Deciphera Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00827138 is a Phase 1 study that has completed, run by Deciphera Pharmaceuticals. The registered enrollment target is 57 participants.
The verdict
NCT00827138, a Phase 1 study, has completed, sponsored by Deciphera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
Rationale: DCC-2036 is a potent broad spectrum inhibitor of BCR-ABL kinase. Inhibition of BCR-ABL has been validated for effective treatment of chronic myeloid leukemia (CML). The emergence of mutant forms of BCR-ABL which resist inhibition by imatinib, dasatinib, and nilotinib is associated with loss of efficacy in treatment of the disease. DCC-2036 is a potent inhibitor of resistant mutants of BCR-ABL including the T315I mutation, and would therefore be expected to effectively treat patients who fail to respond to other BCR-ABL inhibitors. DCC-2036 also inhibits FLT3-ITD, TIE2, KDR, LYN and TRKA kinases. Purpose: to assess the safety and tolerability in patients after continuous administration of DCC-2036 and to determine recommended doses for the conduct of a Phase 2 efficacy trial.
Interventions
- DRUG DCC-2036
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00827138
The ClinicalTrials.gov registry entry for NCT00827138 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Deciphera Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DCC-2036 is the first listed.
NCT00827138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00827138 about?
NCT00827138 is a clinical study titled "Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation)". Rationale: DCC-2036 is a potent broad spectrum inhibitor of BCR-ABL kinase. Inhibition of BCR-ABL has been validated for effective treatment of chronic myeloid leukemia (CML). The emergence of mutant forms of BCR-ABL which resist inhibition by imatinib, dasatinib, and nilotinib is associated with lo...
What is the current status of trial NCT00827138?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2009-03. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00827138?
The interventions under investigation include: DCC-2036 (DRUG).
Who is sponsoring clinical trial NCT00827138?
This trial is sponsored by Deciphera Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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