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Sponsored by: |
Aegera Therapeutics |
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Information provided by: | Aegera Therapeutics |
ClinicalTrials.gov Identifier: | NCT00363974 |
The purpose of this study is to determine if the drug, called AEG35156, can be safely given to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with refractory or relapsed AML.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myelomonocytic, Acute |
Drug: XIAP antisense |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Phase I/II Study of XIAP Antisense AEG35156 Administered to Patients With Refractory/Relapsed AML in Combination With Chemotherapy |
Estimated Enrollment: | 54 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
This is a phase I/II, single-arm, open-label, study to establish the recommended dose and activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions. Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse after an initial CR that lasted less than 6 months or primary refractory AML. Fixed dose of idarubicin and ara-C will be given, plus one of eight doses of AEG35156: 12, 24, 48, 75, 110, 165, 250 and 350mg/m2. A maximum of 54 patients will be treated in cohorts of size 3, starting at 12mg/m2, and not skipping any untried dose level when escalating. Following dose escalation, approximately 20 patients will be treated at the best acceptable dose as determined by the method of Thall and Cook (2004).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subjects with relapsed or refractory AML, except those with APL (acute promyelocytic leukemia), that are about to receive their initial treatment for first relapse after an initial CR that lasted less than 6 months or for primary refractory AML that have an expected complete response rate ≤20%. The initial diagnosis of AML has to be based on the presence of > 10% blasts in marrow or blood, and the diagnosis of relapsed/refractory AML based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100,000 /uL, or neutrophil count < 1000
Subjects must have adequate organ and immune function as indicated by the following laboratory values:
AST (SGOT) and ALT (SGPT) <3 X ULN *
Exclusion Criteria
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
Norris Cancer Center - University of Southern California | |
Los Angeles, California, United States, 90033 | |
United States, Illinois | |
Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Hopital Maisonneuve-Rosemont | |
Montreal, Quebec, Canada |
Study Director: | Jacques Jolivet, MD | Aegera Therapeutics Inc. |
Responsible Party: | Aegera Therapeutics Inc ( Jacques Jolivet, MD, Senior VP Clinical ) |
Study ID Numbers: | AEG35156-103, MDA 2005-0384, PMH 05-0452-C |
Study First Received: | August 10, 2006 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00363974 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
AML leukemia relapse |
refractory antisense oligonucleotide |
Leukemia, Myelomonocytic, Acute Leukemia Leukemia, Myeloid |
Leukemia, Myelomonocytic, Acute Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid |