A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
Description
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients
with advanced solid tumors in order to determine the maximum tolerated dose and select the
recommended Phase 2 dose.
Phase
Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.Inclusion and Exclusion Criteria
- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
- Performance Status of 0 or 1
- Adequate bone marrow, kidney and liver function
- Part 2 includes target expressing NSCLC, ovarian or breast cancer patients
- Brain metastases requiring steroids
- Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
- Active and clinically significant bacterial, fungal, or viral infection
Sites
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California
- Pfizer Investigational Site, Los Angeles, California, 90033
- Keck Hospital of USC, Los Angeles, California, 90033
- Lac & Usc Medical Center, Los Angeles, California, 90033
- USC/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
- Keck Hospital of USC, Los Angeles, California, 90033
- Lac & Usc Medical Center, Los Angeles, California, 90033
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Colorado
- University of Colorado Denver CTO (CTRC), Aurora, Colorado, 88045
- Pfizer Investigational Site, Aurora, Colorado, 88045
- Pfizer Investigational Site, Denver, Colorado, 80045
- Anschutz Cancer Pavilion, Aurora, Colorado, 80045
- University of Colorado Hospital, Denver, Colorado, 80045
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Washington
- University of Washington Medical Center, Seattle, Washington, 98195
- Pfizer Investigational Site, Seattle, Washington, 98109
- Seattle Cancer Care Alliance (Drug Shipment Address), Seattle, Washington, 98109
- Seattle Cancer Care Alliance, Seattle, Washington, 98109