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

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose in combination with azacitidine

Outcome Time Frame:

1 year (anticipated)

Safety Issue:


Principal Investigator

Gregory Reid, MSc, MBA

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

December 2008

Related Keywords:

  • Tumors
  • Refractory solid tumors
  • Phase I/II
  • Refractory and solid tumors



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Duke University Medical Center Durham, North Carolina  27710
Gabrail Cancer Center Canton, Ohio  44718
Veterans Affairs Medical Center Kansas City, Kansas  64128
Pennsylvania Presbyterian Medical Center Philadelphia, Pennsylvania  19104-4283