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A Phase 2, Randomized, Open-Label Study of Azacitidine (Vidaza) vs MGCD0103 vs Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed AML or Intermediate-2 or High-Risk MDS


Phase 2
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

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Trial Information

A Phase 2, Randomized, Open-Label Study of Azacitidine (Vidaza) vs MGCD0103 vs Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed AML or Intermediate-2 or High-Risk MDS


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate as assessed using IWG criteria for AML and MDS

Outcome Time Frame:

After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment

Safety Issue:

No

Principal Investigator

Gregory Reid, MSc, MBA

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.

Authority:

United States: Food and Drug Administration

Study ID:

103 PH GL 2007 CL003

NCT ID:

NCT00666497

Start Date:

June 2008

Completion Date:

April 2009

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Azacitidine
  • Vidaza
  • MGCD0103
  • Histone deacetylase inhibitor
  • DNA methyltransferase inhibitor
  • Epigenetic Therapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096