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NCT00892190 · ClinicalTrials.gov registry record · Phase 1
Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00892190 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 9 participants.
The verdict
NCT00892190, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is an open label, prospective, single institution dose-escalation study. The patient population includes non-induction candidate elderly patients with AML or MDS and/or patients with high-risk or relapsed/refractory AML or MDS. Five dose cohorts will be evaluated using a fixed dose of ATRA in combination with an escalating dose of dasatinib. The investigators will treat with an escalating dose of dasatinib from 70mg to 140mg daily. Dose escalation will proceed in a standard 3+3 fashion. A de-escalation to a 50 mg total daily dose of dasatinib is planned if DLT is greater than or equal to 33% is observed at the first dose level. Once the MTD for the combination of the drugs has been established, up to 6 additional patients will be enrolled at the MTD level to obtain additional safety information about the combination and to allow for preliminary laboratory correlate analysis.
Interventions
- DRUG dasatinib (SPRYCEL)
- DRUG all trans retinoic acid (VESANOID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00892190
The ClinicalTrials.gov registry entry for NCT00892190 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dasatinib (SPRYCEL) is the first listed.
NCT00892190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00892190 about?
NCT00892190 is a clinical study titled "Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome". This is an open label, prospective, single institution dose-escalation study. The patient population includes non-induction candidate elderly patients with AML or MDS and/or patients with high-risk or relapsed/refractory AML or MDS. Five dose cohorts will be evaluated using a fixed dose of ATRA in c...
What is the current status of trial NCT00892190?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-04. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00892190?
The interventions under investigation include: dasatinib (SPRYCEL) (DRUG), all trans retinoic acid (VESANOID) (DRUG).
Who is sponsoring clinical trial NCT00892190?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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