A Phase I/II Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia

NCT00324220 | Completed Phase 1

• 1 other identifier: 0103-005
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 8

Brief Summary

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes or acute myelogenous leukemia.

Conditions

Myelodysplastic Syndrome; Acute Myelogenous Leukemia

Keywords

Phase I/II

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose in combination with azacitidine

  1 year (anticipated)

• Clinical response

  1 year (anticipated)

Secondary Outcomes (3)

• Dose limiting toxicities

  1 year (anticipated)

• Pharmacokinetics

  1 year (anticipated)

• Objective response

  1 year (anticipated)

Study Arms (1)

1

EXPERIMENTAL

MGCD0103 oral administration 3 times per week.

Drug: MGCD0103

Interventions

MGCD0103 DRUG

MGCD0103 Oral administration 3 times per week.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have high-risk MDS (≥ 10% BM blasts) or AML
• RAEB (RA with excess blasts) with ≥10% BM blasts: 10%-20% blasts in BM, \<5% blasts in peripheral blood
• RAEB-T (RAEB in transformation): 21%-30% blasts in BM, \<5% blasts in peripheral blood, absolute monocytosis (\>109/L)
• AML
• Disease may be relapsed/refractory or de novo. Once the MTD has been determined, all subsequent patients in the phase II portion of the study should have no prior azacitidine
• ECOG performance status of 0, 1, or 2
• Age ≥18 years
• Laboratory requirements
• Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the institutional review board/Ethics Committee (IRB/EC)) within 14 days prior to start of treatment

You may not qualify if:

• Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN / cervical in situ)). Prior history of cancer is allowed, as long as there is no active disease
• Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior start of study drug
• WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Examples of acceptable forms of contraception include an oral contraceptive or a double barrier method, such as condom with diaphragm
• Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever \>38.5˚C on the day of scheduled dosing
• Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
• Patients who have been treated with any investigational drug within 30 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy
• Known hypersensitivity to HDAC inhibitors, to any of the components of MG-0103 or Vidaza, including mannitol
• Prior treatment with azacitidine during the expanded phase II portion only
• Known HIV or active Hepatitis B or C
• Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures
• Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take MG-0103 with an acidic drink and recommendation to avoid agents that increase gastric-pH.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (8)

University of Southern California

Los Angeles, California, 90033, United States

Location

St. Francis Hospital & Health Center

Beech Grove, Indiana, 46107, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

mocetinostat

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Gregory Reid, MSc, MBA

  MethylGene Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 10, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

US (8)