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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00542971 |
Purpose
A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS).
Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
AML Acute Myeloid Leukemia Myelodysplastic Disorders |
Drug: Idarubicin Drug: Sorafenib Drug: Ara-C |
Phase I Phase II |
| 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: | Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006), an Oral VEGF, RAF and FLT3 Inhibitor, in Patients With High-risk MDS and AML |
| Enrollment: | 78 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sorafenib + Idarubicin + Ara-C
Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
|
Drug: Idarubicin
12 mg/m2 IV over 1 hour daily (days 1-3)
Other Name: Idamycin®, Idamycin PFS®
Drug: Sorafenib
Starting dose 400 mg by mouth for 7 days
Other Name: Nexavar®
Drug: Ara-C
1.5 g/m2 IV over 24 hours daily (days 1-4)
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Farhad Ravandi-Kashani, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Farhad Ravandi-Kashani, M.D./Associate Professor, The University of Texas M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00542971 History of Changes |
| Other Study ID Numbers: | 2006-0977 |
| Study First Received: | October 10, 2007 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Leukemia AML High-Risk MDS Acute Myeloid Leukemia High-Risk Myelodysplastic Disorder |
Idarubicin Ara-C Cytarabine Sorafenib BAY43-9006 |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Sorafenib Idarubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Protein Kinase Inhibitors Enzyme Inhibitors |