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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00497991 |
The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukaemia |
Drug: AZD1152 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Open Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia. |
Estimated Enrollment: | 70 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clinical Information Center | 1-800-236-9933 | information.center@astrazeneca.com |
Contact: Outside US | 001-866-992-9276 |
United States, New York | |
Research Site | Recruiting |
New York, New York, United States | |
United States, Texas | |
Research Site | Recruiting |
HOUSTON, Texas, United States | |
France | |
Research Site | Recruiting |
ANGERS CEDEX, France | |
Research Site | Recruiting |
GRENOBLE CEDEX, France | |
Research Site | Recruiting |
LE CHESNAY CEDEX, France | |
Italy | |
Research Site | Recruiting |
BOLOGNA, Italy | |
Research Site | Recruiting |
ROMA, Italy | |
Netherlands | |
Research Site | Recruiting |
AMSTERDAM, Netherlands | |
Research Site | Recruiting |
NIJMEGEN, Netherlands | |
Research Site | Recruiting |
ROTTERDAM, Netherlands |
Study Director: | Paul Stockman, MD | AstraZeneca |
Principal Investigator: | Bob Lowenberg, MD, PhD | Cancer Institute |
Study ID Numbers: | D1531C00007, EUDRACT number 2005-004243-65 |
Study First Received: | July 5, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00497991 |
Health Authority: | United States: Food and Drug Administration |
AML phase I/II AZD1152 |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |