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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00892190 |
This is an open label, prospective, single institution dose-escalation study. The patient population includes non-induction candidate elderly patients with AML and/or patients with high-risk or relapsed/refractory AML. 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 40mg to 140mg daily. Dose escalation will proceed in a standard 3+3 fashion. A de-escalation to a 20 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.
Condition | Intervention | Phase |
---|---|---|
Acute Myelogenous Leukemia |
Drug: dasatinib (SPRYCEL) Drug: all trans retinoic acid (VESANOID) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1, Open-Label, Dose-Escalation Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia |
Estimated Enrollment: | 36 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Primary Objective:
Secondary Objectives:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Total bilirubin level ≤1.5 times institutional upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Exclusion Criteria:
Contact: Robert Redner, MD | 412-623-3257 | rednerrl@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute - Hillman Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Robert Redner, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Medical Center ( Robert Redner, MD ) |
Study ID Numbers: | UPCI 08-160 |
Study First Received: | April 30, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892190 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AML Dasatinib all trans retinoic acid relapsed AML |
refractory AML Relapsed/Refractory Acute myelogenous leukemia Elderly subjects (age 65 or older) with acute myelogenous leukemia |
Keratolytic Agents Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Dasatinib |
Tretinoin Leukemia, Myeloid Leukemia, Myeloid, Acute Protein Kinase Inhibitors |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Leukemia, Myeloid Leukemia, Myeloid, Acute Protein Kinase Inhibitors Pharmacologic Actions |
Keratolytic Agents Leukemia Neoplasms Dasatinib Therapeutic Uses Tretinoin Dermatologic Agents |