A Phase 2, Randomized, Open-Label Study of Single Agent Azacitidine (Vidaza®) vs. Single Agent MGCD0103 vs. Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia or Intermediate-2 or High-Risk Myelodysplastic Syndrome

Phase 1

• Conditions: ewly diagnosed Acute Myeloid Leukemia and Intermediate-2, or high-risk Myelodysplastic Syndrome; MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia; MedDRA version: 9.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome

• Registration Number: EUCTR2007-005584-10-GB
• Lead Sponsor: Pharmion Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

•Written informed consent, willingness, and ability to comply with all study procedures;
•Pathologic confirmation of newly diagnosed (de novo or untreated secondary) AML or newly diagnosed Int-2 or high-risk MDS (IPSS classification) per WHO criteria;
•Age = 60 years;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
•Total bilirubin = 1.5 x upper limit of normal (ULN) (unless increased due to Gilbert’s disease or hemolysis);
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x ULN;
•Serum creatinine = 2.0 x ULN; and
•Use of adequate contraception when appropriate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subjects considered fit for intensive chemotherapy who 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. Prior treatments with agents such as hydroxyurea or corticosteroids used for peripheral count control will be allowed;
•Known or suspected hypersensitivity to any components of MGCD0103 capsules or azacitidine formulation components (eg, mannitol);
•Clinical evidence of central nervous system (CNS) involvement by leukemia;
•In blast transformation of chronic myeloid leukemia (CML);
•A diagnosis of promyelocytic leukemia;
•Presence of advanced malignant hepatic tumors;
•Any condition that will put the subject at undue risk or discomfort as a result of adherence to study procedures (eg , requirement to take MGCD0103 with low pH beverage);
•Previous or concurrent malignancy except the following: 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;
•History of gastrointestinal hemorrhage within the last 3 months;
•Known positive serology for hepatitis B surface antigen, hepatitis C antibody; or human immunodeficiency virus; or
•Less than 4 weeks elapsed since any major surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified