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

NCT ID: NCT00697632

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2019-01-31

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MGCD265

Intervention Type: DRUG

Oral daily administration without interruption

Interventions

MGCD265

Oral daily administration without interruption

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

St 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

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency, Vancouver Center

Vancouver, British Columbia, Canada

Jewish General Hospital

Montreal, Quebec, Canada

National Cancer Center

Gyeonggi-do, , South Korea

Seoul National University Hosptial

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

United States; Canada; South Korea

References

Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.

Reference Type: DERIVED

PMID: 36459255 (View on PubMed)

Other Identifiers

265-101

Identifier Type: -

Identifier Source: org_study_id