A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT00585195 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 06-068


PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Bruce Dezube, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute
Jeffrey Clark, MD, Massachusetts General Hospital

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Advanced malignancies (except leukemias), histologically proven at diagnosis which is refractory to standard of care therapy, or for whom no standard of care therapy is available - Solid tumors must have measurable disease - Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis) Exclusion Criteria: - Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the dose level - Prior stem cell transplant except of patients with lymphoma or myeloma - Active or unstable cardiac disease or heart attack within 12 months of starting study treatment
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