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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00697632
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : September 2018
Actual Study Completion Date : January 2019

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




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 1 year [Anticipated] ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 1 year [Anticipated] ]
  2. Pharmacodynamics [ Time Frame: 1 year [Anticipated] ]
  3. Clinical response [ Time Frame: 1 year [Anticipated] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697632


Locations
Show Show 19 study locations
Sponsors and Collaborators
Mirati Therapeutics Inc.
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00697632    
Other Study ID Numbers: 265-101
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Keywords provided by Mirati Therapeutics Inc.:
MET
AXL
VEGFR
NSCLC
HNSCC (Head and neck squamous cell carcinoma)
Tumor
Safety
Phase 1
Solid tumor
Additional relevant MeSH terms:
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Neoplasms