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| Sponsor: | Ariad Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Ariad Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00660920 |
Purpose
The purpose of this study is to determine the maximum tolerated dose or a recommended dose of oral AP24534 in a defined schedule (QD) in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia Hematologic Malignancies |
Drug: Ponatinib, AP24534 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerability and Maximum Tolerated Dose of Oral AP24534 in Patients With Refractory or Advanced Chronic Myelogenous Leukemia and Other Hematologic Malignancies |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Comparison of different dosages of drug given orally once per day.
|
Drug: Ponatinib, AP24534
Comparison of different dosages of drug given orally once per day.
|
The purpose of this study is to determine the maximum tolerated dose or a recommended dose of oral AP24534 in a defined schedule (QD) in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.
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| United States, California | |
| ARIAD Investigational Site #075 | |
| San Francisco, California, United States, 94143 | |
| United States, Michigan | |
| ARIAD Investigational Site #011 | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Oregon | |
| ARIAD Investigational Site #048 | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| ARIAD Investigational Site #076 | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| ARIAD Investigational Site #005 | |
| Houston, Texas, United States, 70030 | |
| Study Director: | Medical Monitor | Ariad Pharmaceuticals |
More Information
| Responsible Party: | Ariad Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00660920 History of Changes |
| Other Study ID Numbers: | AP24534-07-101 |
| Study First Received: | April 15, 2008 |
| Last Updated: | September 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Hematologic Neoplasms |
Neoplasms by Histologic Type Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Neoplasms by Site |