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Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Advanced Malignancies

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Trial Information

Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase
inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice.
Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.

In this study, MGCD265 is orally administered on a daily basis to patients with advanced

Inclusion Criteria:

- Patients with advanced metastatic or unresectable malignancy that is refractory to
standard therapy and/or existing therapies are not likely to achieve clinical
benefit, and/or the patient declines to receive standard treatment such as
chemotherapy. The patient's disease must be histologically confirmed;

- Evaluable disease;

- Last dose of prior chemotherapy, radiation therapy, or investigational agents
occurred at least 4 weeks before the start of therapy on Cycle 1 Day 1;

- Recovery from the adverse effects of prior therapy at the time of enrollment to ≤
grade 1 (excluding alopecia);

- Age ≥ 18 years;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;

- Life expectancy greater than 3 months following study entry;

- Adequate renal function;

- Adequate hepatic parameters;

- Adequate bone marrow function;

- A negative serum pregnancy test at screening for women of childbearing potential

- Agreement by WOCBP or men whose sexual partners are WOCBP to use two methods of
adequate contraception (e.g., hormonal and barrier method) prior to study entry and
for the duration of the study. WOCBP and men whose sexual partners are WOCBP must
continue to use two methods of contraception for 28 days and 90 days, respectively,
after the last dose of study medication;

- Ability to understand and willingness to sign a written informed consent document;

- Willingness and ability to comply with study visits and activities to be performed
only at the study center; and

- For the Expanded MTD Cohort, the subject must have tumors that are accessible to

Exclusion Criteria:

- Subjects with uncontrolled concurrent illness;

- Subjects with a history of a cardiovascular illness;

- Subjects with QTc > 470 msec (including subjects on medication);

- Subjects with left ventricular ejection fraction (LVEF) < 50%;

- Subjects with leukemias or myelodysplastic syndrome;

- Immunocompromised subjects;

- Subjects with a history of autologous bone marrow transplant (BMT) within the
previous five years, or subjects with organ transplants or allogeneic BMT;

- Subjects with lung tumor lesions with increased likelihood of bleeding, including:
history of hemoptysis; evidence of cavitation; and invasion of aorta or pulmonary
arteries by the tumor;

- Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4
weeks from last cranial radiation or 2 weeks from last steroids);

- Subjects unable to swallow oral medications or with pre-existing gastrointestinal
disorders that might interfere with proper absorption of oral drugs;

- Subjects with a history of major surgery within 28 days of first receipt of study

- Nursing or pregnant women;

- Subjects with any other diseases, metabolic dysfunction, physical examination
finding, or clinical laboratory finding that, in the opinion of the Investigator,
contraindicates the use of MGCD265 Drug Product or that may render the subject at
excessively high risk for treatment complications; or

- Subjects with a known hypersensitivity to any of the components of the MGCD265 Drug

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

1 year [Anticipated]

Safety Issue:


Principal Investigator

Manuela Juretic

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

December 2013

Related Keywords:

  • Advanced Malignancies
  • c-Met
  • Ron
  • Cancer
  • Tumor
  • Safety
  • Phase 1
  • Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Duke University Medical Center Durham, North Carolina  27710