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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: MGCD265

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency, Vancouver Center
  • Quebec
    • Montreal, Quebec, Canada, H3T IE2
      • Jewish General Hospital
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 410-769
    • National Cancer Center
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul national university hosptial
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
    • San Diego, California, United States, 92093
      • UC San Diego
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University, Alvin J. Siteman Cancer Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University, Herbert Irving Comprehensive Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas, MD Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

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:

• 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 patients enrolling in the four expansion cohorts:

  • NSCLC patients must meet criteria for MET and/or Axl expression or,
  • HNSCC patients must meet criteria for MET and/or Axl expression or,
  • NSCLC patients must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
  • Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MGCD265; Oral daily administration without interruption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability	1 year [Anticipated]

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	1 year [Anticipated]
Pharmacodynamics	1 year [Anticipated]
Clinical response	1 year [Anticipated]

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: May 14, 2008
• First Submitted That Met QC Criteria: June 12, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Safety; NSCLC; MET; Phase 1; Solid tumor; VEGFR; Tumor; AXL; HNSCC (Head and neck squamous cell carcinoma)
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 265-101