Clinical Trials /

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

NCT00697632

Description:

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

Related Conditions:
  • Cancer
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
  • 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 IDs

  • ORG STUDY ID: 265-101
  • NCT ID: NCT00697632

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
MGCD2651

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
1Experimental
  • MGCD265

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability
Time Frame:1 year [Anticipated]
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetics
Time Frame:1 year [Anticipated]
Safety Issue:
Description:
Measure:Pharmacodynamics
Time Frame:1 year [Anticipated]
Safety Issue:
Description:
Measure:Clinical response
Time Frame:1 year [Anticipated]
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • MET
  • AXL
  • VEGFR
  • NSCLC
  • HNSCC (Head and neck squamous cell carcinoma)
  • Tumor
  • Safety
  • Phase 1
  • Solid tumor

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