Alisertib for Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01779843|
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : February 17, 2017
This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. As part of this research study, you will take alisertib in combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for your cancer. However, cytarabine and idarubicin have both been approved by the FDA for treatment of AML. It also means that the FDA has not approved giving alisertib with idarubicin and cytarabine for use in patients, including patients with your type of cancer.
Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest that alisertib may slow down the spread of your cancer. It does this by blocking certain substances needed by the cancer cells to spread. In this study, researchers would like to combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML.
The primary purpose of this research study is to determine the highest dose that alisertib can be given with idarubicin and cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Drug: Cytarabine Drug: Idarubicin Drug: Alisertib||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Aurora A Kinase Inhibitor Alisertib in Combination With 7+3 Induction Chemotherapy in Patients With Acute Myeloid Leukemia|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2016|
Induction: 100 mg/m2/day Cytarabine intravenous, days 1-7 of induction cycle. 12 mg/m2/day Idarubicin intravenous, days 1-3. Alisertib orally, twice a day for one week starting on day 8, dose escalation-starting dose 10 mg PO BID.
Consolidation: Cytarabine 3 g/m2 by IV infusion over 3 hours given every 12 hours on Days 1, 3 and 5 (subjects younger than age 60) or Cytarabine 2 g/m2 per day by IV infusion over 3 hours on days 1-5 (subjects at or older than age 60)
Other Name: MLN8237
- Maximum Tolerated Dose of Alisertib in combination with 7+3 induction chemotherapy [ Time Frame: 2 years ]The maximum tolerated dose (MTD) of the aurora kinase A inhibitor alisertib (MLN8237) in combination with 7+3 induction chemotherapy in patients with acute myeloid leukemia
- Evaluate safety and tolerability of alisertib, including number of adverse events and severity. [ Time Frame: 2 years ]The number and severity of adverse events associated with this treatment.
- Severity and number of all trial-related toxicities [ Time Frame: 2 years ]To detect and categorize, according to severity, the cumulative incidences of drug related toxicities
- Rates of response [ Time Frame: 2 years ]To determine the response rate, including rates of complete and partial remission
- One-year relapse-free and overall survival [ Time Frame: 2 years ]To measure the one-year relapse-free and overall survival after treatment
- Measurement of tumor mitotic index, Ki67 and cPARP statining, Pharmacodynamic parameters for aurora kinase A inhibition, during treatment [ Time Frame: 2 years ]To assess pharmacodynamic effects of aurora kinase A inhibition, including tumor mitotic index, Ki67 and cPARP staining
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779843
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Amir Fathi, MD||Massachusetts General Hospital|