Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital Millennium Pharmaceuticals, Inc. |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00505700 |
The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and idarubicin. Various molecular markers associated with response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray analyses. The study endpoints are maximum tolerated dose and response to treatment.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: velcade Drug: Idarubicin Drug: Cytarabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment |
Official Title: | Phase I Dose Escalating Trial of VELCADE (PS-341) in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel/ Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Philip C Amrein, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Philip Amrein, MD ) |
Study ID Numbers: | 03-103 |
Study First Received: | July 19, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00505700 |
Health Authority: | United States: Food and Drug Administration |
acute myeloid leukemia |
Leukemia Idarubicin Bortezomib Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses |