A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
Completed · Phase 1
Conditions studied: Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
In brief
Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.
Key facts
- Study ID
- NCT02573259
- Run by
- Pfizer
- People needed
- 147
- Starts
- 2016-02-10
- Expected to finish
- 2020-11-19
- Last updated by the study team
- 2021-12-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ronald Reagan Medical Center, Department of Radiological Sciences — Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
- UCLA Hematology & Oncology Clinic — Los Angeles, California, United States
- Santa Monica UCLA Hematology & Oncology Clinic — Santa Monica, California, United States
- Norton Cancer Institute, Multidisciplinary Clinic — Louisville, Kentucky, United States
- Norton Cancer Institute, Norton Healthcare Pavilion — Louisville, Kentucky, United States
- Norton Hospital — Louisville, Kentucky, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- University of Rochester — Rochester, New York, United States
- UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Tennessee Oncology, PLLC — Dickson, Tennessee, United States
- Tennessee Oncology, PLLC — Franklin, Tennessee, United States
- Tennessee Oncology, PLLC — Gallatin, Tennessee, United States
- Tennessee Oncology, PLLC — Hermitage, Tennessee, United States
- Tennessee Oncology, PLLC — Lebanon, Tennessee, United States
- Tennessee Oncology, PLLC — Murfreesboro, Tennessee, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
- The Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
- Tennessee Oncology, PLLC — Shelbyville, Tennessee, United States
- Tennessee Oncology, PLLC — Smyrna, Tennessee, United States
- MHAT Uni Hospital OOD — Panagyurishte, Pazardzhik, Bulgaria
- Clinical Research Unit — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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