E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes
The goal of this clinical research study is to learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes|
- Overall Response [ Time Frame: 21 days ] [ Designated as safety issue: No ]Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (CR + CRp + PR+ marrow clearance of blast) during Stage 1 and 2. The sample size and stopping rules determined according to Simon's two-stage design. Overall response (CR + CRp + PR) rate and its 95% confidence interval estimated using a binomial distribution. Overall survival and progression free survival functions estimated using the Kaplan-Meier method.
- Toxicity Profile [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Bayesian sequential monitoring method (Thall, 1995) used to monitor toxicity. Toxic event defined as death or a CTCAE 4.0 grade 3/4 non-hematological toxicity related to study drug lasting or 7 days or more. Toxicity reported by type, frequency and severity. Worst toxicity grades per patient tabulated for selected adverse events and laboratory measurements.
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
Experimental: Stage 1: E7070
Stage 1: E7070 400 mg/m2 by vein (IV) over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only). If at assessment patient is found to be in CR, CRp, PR or marrow clearance of blasts, the patient may receive post-remission therapy with E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) every 3 weeks for up to five additional cycles as long as patient continues to have clinical benefit.
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
Experimental: Stage 2: E7070 + Idarubicin + Cytarabine
Stage 2: E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.Drug: Idarubicin
8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
Other Name: IdamycinDrug: Cytarabine
1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
Other Names:Drug: Dexamethasone
10 mg by vein daily for 3 - 4 days with cytarabine.
Other Name: Decadron
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|Contact: Gautam Borthakur, MBBS||713-563-1586|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur, MBBS||UT MD Anderson Cancer Center|