Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
1 other identifier
interventional
180
3 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2008
Longer than P75 for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFebruary 12, 2019
February 1, 2019
10.3 years
May 14, 2008
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
1 year [Anticipated]
Secondary Outcomes (3)
Pharmacokinetics
1 year [Anticipated]
Pharmacodynamics
1 year [Anticipated]
Clinical response
1 year [Anticipated]
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
City of Hope
Duarte, California, 91010, United States
UC Irvine Medical Center
Orange, California, 92868, United States
UC San Diego
San Diego, California, 92093, United States
University of Chicago
Chicago, Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Washington University, Alvin J. Siteman Cancer Center
St Louis, Missouri, 63110, United States
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency, Vancouver Center
Vancouver, British Columbia, V5Z 4E6, Canada
Jewish General Hospital
Montreal, Quebec, H3T IE2, Canada
National Cancer Center
Gyeonggi-do, 410-769, South Korea
Seoul National University Hosptial
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Related Publications (1)
Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.
PMID: 36459255DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2008
First Posted
June 16, 2008
Study Start
June 1, 2008
Primary Completion
September 1, 2018
Study Completion
January 1, 2019
Last Updated
February 12, 2019
Record last verified: 2019-02