A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00431873
First received: February 2, 2007
Last updated: October 23, 2013
Last verified: October 2013

February 2, 2007
October 23, 2013
January 2007
November 2008   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
Determine the overall response rate (CR + PR) with MG-0103 in patients with CLL that is refractory to prior therapy.
Complete list of historical versions of study NCT00431873 on ClinicalTrials.gov Archive Site
  • Duration of objective response [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics (biomarkers) [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Estimate duration of objective response.
  • Characterize the safety profile of MG-0103.
  • Assess biomarkers and predictive markers for MG-0103.
  • Evaluate pharmacokinetic parameters of MG-0103 with a gastric acid lowering agent and with a high fat meal (for patients at selected centers).
  • For patients who have disease that fails to respond or progresses on MG-0103, evaluate MG-0103 in combination with rituximab, response rate and safety.
Not Provided
Not Provided
 
A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia
A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with refractory chronic lymphocytic leukemia.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphocytic Leukemia, Chronic
Drug: MGCD0103
MGCD0103 Administered orally three times per week.
Experimental: 1
MGCD0103 administered orally three times per week.
Intervention: Drug: MGCD0103
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologic confirmation of CLL.
  • Prior Treatment. There will be no limit to prior therapy. Therapy with fludarabine and Rituxan must have failed (disease progression, intolerance, or not a candidate).
  • Age 18 years or greater.
  • ECOG performance status of 0 or 1.
  • Laboratory requirements (must be done within 7 days prior to study initiation):

    • Total Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN).
    • Aspartate transaminase (AST/SGOT) and Alanine transaminase (ALT/SGPT) ≤ 2.5 x ULN.
    • Serum Creatinine ≤1 .5 x ULN.
  • 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.

Exclusion Criteria:

  • Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ) or melanoma 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. An example of an acceptable form of contraception is a double barrier method, such as condom with diaphragm.
  • Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5ºC (not due to tumor fever) 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 28 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. Patients must have recovered from all transient toxicity induced by prior therapy.
  • Known hypersensitivity to HDAC inhibitors, to any of the components of MG-0103 (refer to IB). Patients who have known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab will not be allowed to receive rituximab concomitantly on this study.
  • Known human immunodeficiency virus (HIV) or known active Hepatitis B or C. Testing is not required for patients not suspected of having these conditions. For patients with a history of Hepatitis B or C that is no longer active, the Investigator should contact MethylGene in advance to confirm patient's eligibility.
  • 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 a low-pH drink and recommendation to avoid agents that increase gastric-pH.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00431873
0103-009
No
Gregory Reid, Chief Medical Officer, MethylGene, Inc.
MethylGene Inc.
Not Provided
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
MethylGene Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP