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

Sponsor

Mirati Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00697632

Collaborator

(none)

180

Enrollment

Locations

Arm

127

Duration (Months)

9.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Drug: MGCD265	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: MGCD265

Oral daily administration without interruption

Outcome Measures

Primary Outcome Measures

Safety and tolerability [1 year [Anticipated]]

Secondary Outcome Measures

Pharmacokinetics [1 year [Anticipated]]
Pharmacodynamics [1 year [Anticipated]]
Clinical response [1 year [Anticipated]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	UC Irvine Medical Center	Orange	California	United States	92868
3	UC San Diego	San Diego	California	United States	92093
4	University of Chicago	Chicago	Illinois	United States	60637
5	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
6	Washington University, Alvin J. Siteman Cancer Center	Saint Louis	Missouri	United States	63110
7	Columbia University, Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
8	Duke University Medical Center	Durham	North Carolina	United States	27710
9	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
10	University of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030
11	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
12	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
13	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
14	British Columbia Cancer Agency, Vancouver Center	Vancouver	British Columbia	Canada	V5Z 4E6
15	Jewish General Hospital	Montreal	Quebec	Canada	H3T IE2
16	National Cancer Center	Gyeonggi-do		Korea, Republic of	410-769
17	Seoul National University Hosptial	Seoul		Korea, Republic of	110-744
18	Samsung Medical Center	Seoul		Korea, Republic of	135-710
19	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of