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

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697632
• Other study ID #: 265-101
• Status: Completed
• Phase: Phase 1
• Start date: June 2008
• Est. completion date: January 2019

Study information

• Verified date: February 2019
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• MGCD265
Oral daily administration without interruption

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Jewish General Hospital	Montreal	Quebec
Canada	British Columbia Cancer Agency, Vancouver Center	Vancouver	British Columbia
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hosptial	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	Columbia University, Herbert Irving Comprehensive Cancer Center	New York	New York
United States	UC Irvine Medical Center	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Washington University, Alvin J. Siteman Cancer Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	UC San Diego	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		1 year [Anticipated]
Secondary	Pharmacokinetics		1 year [Anticipated]
Secondary	Pharmacodynamics		1 year [Anticipated]
Secondary	Clinical response		1 year [Anticipated]