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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by MethylGene Inc.
Sponsor:
Information provided by (Responsible Party):
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00697632
First received: May 14, 2008
Last updated: October 16, 2014
Last verified: October 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 Cancer
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: 150
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:

  • 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.
  • Evaluable disease;
  • Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
  • Recovery from the adverse effects ≤ grade 1;
  • Acceptable ECOG status 0, 1, or 2;
  • Life expectancy greater than 3 months following study entry;
  • Adequate laboratory values;
  • For the expansion cohorts, positive for specific activating MET mutations, MET amplifications, and/or AXL fusions.

Exclusion Criteria:

  • Uncontrolled concurrent illness;
  • History of cardiovascular illness;
  • QTc > 470 msec (including subjects on medication);
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Immunocompromised subjects;
  • History of bone marrow transplant;
  • Lung tumor lesions with increased likelihood of bleeding;
  • Symptomatic or uncontrolled brain metastases;
  • Unable to swallow oral medications or with pre-existing gastrointestinal disorders.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697632

Contacts
Contact: Vanessa Tassell 858-332-3410
Contact: Mary Collier 858-332-3410

Locations
United States, California
UC San Diego Not yet recruiting
San Diego, California, United States, 92093
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
United States, Pennsylvania
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
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: October 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
MET
AXL
VEGFR
NSCLC
HNSCC (Head and neck squamous cell carcinoma)
Tumor
Safety
Phase 1

ClinicalTrials.gov processed this record on October 20, 2014