Tosedostat and Cytarabine or Azacitidine in Treating Older Participants With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01636609|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2012
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia High Risk Myelodysplastic Syndrome||Drug: Azacitidine Drug: Cytarabine Drug: Tosedostat||Phase 1 Phase 2|
I. To determine the safety profile of tosedostat (oral) in combination with cytarabine (subcutaneous [SQ]) or azacitidine (5-azacytidine) in patients age 60 years or older with relapsed/refractory acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).
II. To observe the anti-tumor effects of tosedostat in combination with cytarabine or 5-azacytidine, if any occur.
OUTLINE: This is a phase I, dose-escalation of cytarabine and azacitidine followed by a phase II study. Participants are assigned to 1 of 2 arms.
ARM I: Participants receive tosedostat orally (PO) once daily (QD) on days 1-28 and cytarabine subcutaneously (SC) twice daily (BID) on days 1-10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Participants receive tosedostat PO QD on days 1-28 and azacitidine intravenously (IV) over 10-40 minutes or SC for on days 1-7. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants will be followed up at 28 days and then every 3-5 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Cytarabine or 5-Azacitidine Combined With Tosedostat to Evaluate the Safety and Tolerability in Older Patients With Acute Myeloid Leukemia (AML) or High Risk MDS|
|Actual Study Start Date :||November 20, 2012|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Experimental: Arm I (tosedostat, cytarabine)
Participants receive tosedostat PO QD on days 1-28 and cytarabine SC BID on days 1-10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (tosedostat, azacitidine)
Participants receive tosedostat PO QD on days 1-28 and azacitidine IV over 10-40 minutes or SC on days 1-7. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Given IV or SC
- Maximum tolerated dose of cytarabine and azacitidine (Phase I) [ Time Frame: Up to 28 days ]
- Overall response defined as complete response (CR), CR with incomplete platelet recovery (CRp) or CR with insufficient hematological recovery (CRi), morphologic leukemia free state (MLF), partial response (PR), or hematologic improvement (HI) [ Time Frame: Up to 6 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636609
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge Cortes||M.D. Anderson Cancer Center|