Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

This study is currently recruiting participants.
Verified January 2014 by MethylGene Inc.
Sponsor:
Information provided by (Responsible Party):
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00697632
First received: May 14, 2008
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.


Condition Intervention Phase
Advanced Malignancies
Drug: MGCD265
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by MethylGene Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year [Anticipated] ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 1 year [Anticipated] ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: 1 year [Anticipated] ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: 1 year [Anticipated] ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MGCD265
Oral daily administration without interruption

Detailed Description:

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 malignancies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (WOCBP);
  • 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 biopsy.

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 drug;
  • 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 Product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697632

Contacts
Contact: Vanessa Tassell 858-332-3410 tassellv@mirati.com
Contact: Mary Collier 858-332-3410 collierm@mirati.com

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G1Z2
Canada, British Columbia
British Columbia Cancer Agency, Vancouver Center Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
MethylGene Inc.
Investigators
Study Director: Vanessa Tassell MethylGene Inc.
  More Information

No publications provided

Responsible Party: MethylGene Inc.
ClinicalTrials.gov Identifier: NCT00697632     History of Changes
Other Study ID Numbers: 265-101
Study First Received: May 14, 2008
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
c-Met
VEGFR
Ron
Cancer
Tumor
Safety
Phase 1

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 21, 2014