|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00892190 |
Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia |
Drug: dasatinib (SPRYCEL) Drug: all trans retinoic acid (VESANOID) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 24 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Primary Objective:
1. To determine the safety and tolerability of the combination of dasatinib and ATRA in relapsed or elderly, non-induction candidate acute myelogenous leukemia (AML) patients and to identify the maximally tolerated dose (MTD), dose-limiting toxicities (DLT).
Secondary Objectives:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert Redner, MD | 412-623-3257 | rednerrl@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute - Hillman Cancer Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Principal Investigator: | Robert Redner, MD | University of Pittsburgh |
More Information
| Responsible Party: | Robert Redner, MD, University of Pittsburgh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00892190 History of Changes |
| Other Study ID Numbers: | UPCI 08-160 |
| Study First Received: | April 30, 2009 |
| Last Updated: | April 26, 2011 |
| 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 |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Tretinoin Dasatinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Keratolytic Agents Dermatologic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |