Status:
TERMINATED
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.
Detailed Description
This randomized, 3-arm Phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome \[MDS\]) to that of single-agen...
Eligibility Criteria
Inclusion
- Able to provide written informed consent, and be willing and able to comply with all the study procedures
- Must be 60 years of age or older
- Must have a pathologic confirmation of newly diagnosed (de novo or untreated secondary) AML or newly diagnosed Int-2 or high-risk MDS (IPSS classification) according to WHO criteria
- Must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Must have adequate organ function, including total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST \& ALT ≤ 2.5 x ULN; and serum creatinine ≤ 2.0 x ULN.
Exclusion
- Considered fit for intensive chemotherapy and opt to be treated with intensive chemotherapy
- Prior transplantation or any prior anticancer therapy (standard or investigational, including chemotherapy, treatment with HDAC inhibitors, or combination HDAC and azacitidine) administered to treat AML or MDS.
- Clinical evidence of central nervous system (CNS) involvement by leukemia
- A diagnosis of promyelocytic leukemia
- Previous or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry
- Active and uncontrolled clinically significant infection
- Known positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
- Less than 4 weeks elapsed since any major surgery
- Any prior or active disease that may interfere with the procedures or evaluations to be conducted in the study
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00666497
Start Date
June 1 2008
End Date
April 1 2009
Last Update
May 8 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Diamond Centre, Leukemia/BMT Program of BC
Vancouver, British Columbia, Canada, V5Z 4E3
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
4
University Hospital
Birmingham, United Kingdom, B15 2TH