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

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: MGCD265

• Registration Number: NCT00697632
• Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-05-14
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-16
• Primary Completion: 2018-09
• Study Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MGCD265	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	1 year [Anticipated]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	1 year [Anticipated]
Pharmacodynamics	1 year [Anticipated]
Clinical response	1 year [Anticipated]

Trial Locations

Locations (19)

City of Hope; 🇺🇸 Duarte, California, United States

UC Irvine Medical Center; 🇺🇸 Orange, California, United States

UC San Diego; 🇺🇸 San Diego, California, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Washington University, Alvin J. Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Columbia University, Herbert Irving Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

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