Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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-agent MGCD0103 and to that of combination therapy with MGCD0103 and azacitidine in elderly patients with acute myelogenous leukemia (AML) or intermediate-2 (Int-2) or high-risk MDS, for whom no standard of care exists. The goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent Phase 3 study of elderly subjects with AML or Int-2 or high-risk MDS.

Conditions

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Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Azacitidine

Group Type EXPERIMENTAL

Azacitidine

Intervention Type DRUG

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

B

MGCD0103

Group Type EXPERIMENTAL

MGCD0103

Intervention Type DRUG

90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle

C

Azacitidine + MGCD0103

Group Type EXPERIMENTAL

Azacitidine

Intervention Type DRUG

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

MGCD0103

Intervention Type DRUG

90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle

Interventions

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Azacitidine

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

Intervention Type DRUG

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle

Intervention Type DRUG

MGCD0103

90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle

Intervention Type DRUG

Other Intervention Names

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Vidaza

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No