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Study of MGCD0103 Given Three-Times Weekly in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323934
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : January 8, 2015
Information provided by:
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 10, 2006
Last Update Posted Date January 8, 2015
Study Start Date  ICMJE April 2004
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Safety and tolerability [ Time Frame: 1 year (anticipated) ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2006)
  • To assess the safety and tolerability of increasing doses of MGCD0103 when administered to patients with advanced solid malignancies or aggressive Non-Hodgkin's Lymphoma (NHL).
  • To determine the maximally tolerated dose (MTD), the dose effecting the maximal change in biomarkers (if lower than MTD), and the dose limiting toxicity(ies)(DLT) of MGCD0103.
  • Safety will be evaluated by: physical examination, vital signs, ECG, adverse experiences and laboratory assessment including hematology, clinical chemistry and urinalysis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Clinical response [ Time Frame: 1 year (anticipated) ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ]
  • Pharmacodynamics (histone acetylation; biomarkers) [ Time Frame: 1 year (anticipated) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2006)
  • Pharmacokinetics assays for MGCD0103 will be performed pre-dose and post-dose over a 24-hour period on each of Days 1 and 11 in Cycle 1.
  • Histone (H3 + H4) acetylation will be analyzed in buffy coats at different time intervals during the trial.
  • Clinical response will be evaluated using RECIST. Criteria for solid tumors and by the response criteria for NHL for lymphoma, according to two methods:
  • Overall response, composed of PR + CR (traditional method).
  • Extended response composed of PR + CR + prolonged SD (defined as 6 cycles of treatment)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of MGCD0103 Given Three-Times Weekly in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Brief Summary In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with advanced solid tumors or Non-Hodgkin's Lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tumors
  • Non Hodgkin's Lymphoma
Intervention  ICMJE Drug: MGCD0103
Oral dosage 2 times weekly.
Study Arms  ICMJE Experimental: 1
MGCD0103 Oral 2 times weekly
Intervention: Drug: MGCD0103
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)
Original Enrollment  ICMJE
 (submitted: May 8, 2006)
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically or cytologically documented advanced or metastatic solid malignancy or aggressive NHL with no reasonable likelihood of achieving clinical benefit with existing therapies, that has failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists. Aggressive forms of NHL eligible for the study are:

    • Burkitt's lymphoma
    • Mantle cell lymphoma
    • Diffuse large B-cell lymphoma
    • Follicle-center cell lymphoma, large cell
    • Primary mediastinal large B-cell lymphoma
  • Patients with known central nervous system (CNS) metastases may be enrolled if they have received radiotherapy for their CNS disease, if they have been on a stable dose of steroids for at least 1 month prior to study entry, if they have had computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 1 month of study entry that shows stable disease and if they are free of neurological symptoms.
  • Prior therapies allowed:

    • Cytotoxic therapy
    • Hormonal therapy/other therapy
    • Luteinizing hormone releasing hormone (LHRH) agonist therapy
    • Radiation
    • Surgery
    • Adjuvant therapy - Patients may have had unlimited prior adjuvant therapy. A minimum of 28 days must have passed since the end of last treatment and study initiation. Patients must have recovered from any treatment-related toxicities.
  • ECOG performance status of 0, 1, or 2.
  • Age ≥ 18 years.
  • Minimum life expectancy of at least 3 months.
  • Laboratory requirements

Exclusion Criteria:

  • Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ) unless the previous cancer was treated and the patient has remained disease free for five years or more prior to the current cancer diagnosis. Investigators desiring to enter patients with a second malignancy must discuss with and obtain written approval in advance from the MethylGene Medical Monitor.
  • Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test documented within 7 days prior to registration on study.
  • Patients and their partners, if either are of child-bearing potential, not using adequate birth control measures throughout the course of the study. Both men and women enrolled on study must agree to use a medically acceptable effective form of contraception during the study and for 90 days following the last dose of study medication. An effective form of contraception is an oral contraceptive or a double barrier method, such as condom with diaphragm.
  • Patients with known meningeal metastasis(es)
  • Patients with active or uncontrolled infections, or with a fever > 38.5 degrees Celsius 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 histone deacetylase (HDAC) inhibitors or any of the components of MGCD0103
  • Known HIV or hepatitis B or C (active, prior treated, or both).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00323934
Other Study ID Numbers  ICMJE 0103-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gregory Reid, Chief Medical Officer, MethylGene, Inc.
Study Sponsor  ICMJE Mirati Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date January 2015

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