Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Drug: MGCD265 | Phase 1 |
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 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 |
- Safety and tolerability [ Time Frame: 1 year [Anticipated] ]
- Pharmacokinetics [ Time Frame: 1 year [Anticipated] ]
- Pharmacodynamics [ Time Frame: 1 year [Anticipated] ]
- Clinical response [ Time Frame: 1 year [Anticipated] ]

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

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

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