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A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine

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: NCT00372437
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : July 1, 2015
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours.

Condition or disease Intervention/treatment Phase
Tumors Drug: MGCD0103 Drug: Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine
Study Start Date : September 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: MGCD0103
MGCD0103 as an oral dose three times per week.

Drug: Gemcitabine
Gemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle.

Primary Outcome Measures :
  1. Maximum tolerated dose in combination with azacitidine [ Time Frame: 1 year (anticipated) ]
  2. Response rate [ Time Frame: 1 year (anticipated) ]

Secondary Outcome Measures :
  1. Objective response. [ Time Frame: 1 year (anticipated) ]
  2. Pharmacodynamics (histone acetylation, biomarkers) [ Time Frame: 1 year (anticipated) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically documented cancer: Phase I--solid tumors where gemcitabine is considered standard of care; refractory solid tumor 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. Phase II--locally advanced and measurable (non-resectable III) or metastatic (Stage IV) pancreatic cancer.
  • Patients with known CNS metastases may be enrolled on Phase I or II only if they meet the following criteria:

    • They have received radiotherapy for their CNS disease;
    • They have had steroids discontinued for at least 1 month prior to study entry;
    • They have had a CT or MRI of the brain within 1 month of study entry that shows stable disease; and d)they are free of neurological symptoms.
  • Karnofsky performance status of 70 or greater.
  • Age 18 years and over.
  • Laboratory requirements (must be done within 14 days prior to study initiation):

    • Hematology: White Blood Cells (WBC)≥3 x 10<9>/L (≥ 3000/mm3);
    • Absolute Neutrophil Count (ANC) ≥1.5 x 10<9>/L (≥1500/mm3);
    • Platelets ≥100 x 10<9>/L (≥100,000/mm3);
    • Chemistry: Total Bilirubin ≤1.5 x Upper Limit of Normal(ULN);
    • AST(SGOT)and ALT(SGPT)≤3 x ULN; ≤ 5 x ULN if documented liver metastases;
    • Serum Creatinine ≤1.5 x ULN or calculated creatinine clearance ≥50 mL/min;
    • Urinalysis: Proteinuria <1 mg/dl or 500 mg protein/24 hours if dipstick ≥2+.
  • Patients or their legal representative must be able to read (or have read to them), 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). (Phase II portion only)
  • Pregnant or lactating women. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to starting 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. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
  • Patients with uncontrolled concomitant illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever >38.5C 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.
  • Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
  • Known hypersensitivity to gemcitabine.
  • Prior treatment with gemcitabine (during the expanded phase II portion only).
  • Known HIV or known 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 a low pH drink and recommendation to avoid agents that increase gastric pH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372437

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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
Veterans Affairs Medical Center
Kansas City, Kansas, United States, 64128
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Pennsylvania
Pennsylvania Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
Canada, Quebec
McGill University/Dept Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUS Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Mirati Therapeutics Inc.
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Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
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Responsible Party: Mirati Therapeutics Inc. Identifier: NCT00372437    
Other Study ID Numbers: 0103-006
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Mirati Therapeutics Inc.:
Refractory solid tumors
Phase I/II
Refractory and solid tumors
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Histone Deacetylase Inhibitors