- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372437
A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine
June 4, 2015 updated by: Mirati Therapeutics Inc.
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University/Dept Oncology
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Sherbrooke, Quebec, Canada, J1H 5N4
- CHUS Hopital Fleurimont
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Cancer Center
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Kansas
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Kansas City, Kansas, United States, 64128
- Veterans Affairs Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4283
- Pennsylvania Presbyterian Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232-6307
- Vanderbilt University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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MGCD0103 as an oral dose three times per week.
Gemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose in combination with azacitidine
Time Frame: 1 year (anticipated)
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1 year (anticipated)
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Response rate
Time Frame: 1 year (anticipated)
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1 year (anticipated)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response.
Time Frame: 1 year (anticipated)
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1 year (anticipated)
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Pharmacodynamics (histone acetylation, biomarkers)
Time Frame: 1 year (anticipated)
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1 year (anticipated)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 5, 2006
First Submitted That Met QC Criteria
September 6, 2006
First Posted (Estimate)
September 7, 2006
Study Record Updates
Last Update Posted (Estimate)
July 1, 2015
Last Update Submitted That Met QC Criteria
June 4, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Histone Deacetylase Inhibitors
- Gemcitabine
- Mocetinostat
Other Study ID Numbers
- 0103-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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