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
Public ClinicalTrials.gov record NCT02573259. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-06801591 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC MELANOMA, SQUAMOUS CELL HEAD AND NECK CANCER, OVARIAN CANCER, SARCOMA, NON-SMALL CELL LUNG CANCER, UROTHELIAL CARCINOMA OR OTHER SOLID TUMORS.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02573259
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 147 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 10, 2016 (Actual)
- Primary completion
- Nov 19, 2020 (Actual)
- Completion
- Nov 19, 2020 (Actual)
- Last update posted
- Dec 13, 2021
2016 – 2020
United States locations
- U.S. sites
- 24
- U.S. states
- 6
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Unit | Los Angeles | California | 90024 | — |
| Ronald Reagan Medical Center, Department of Radiological Sciences | Los Angeles | California | 90095 | — |
| Ronald Reagan UCLA Medical Center, Drug Information Center | Los Angeles | California | 90095 | — |
| UCLA Hematology & Oncology Clinic | Los Angeles | California | 90095 | — |
| Santa Monica UCLA Hematology & Oncology Clinic | Santa Monica | California | 90404 | — |
| Norton Cancer Institute, Multidisciplinary Clinic | Louisville | Kentucky | 40202 | — |
| Norton Cancer Institute, Norton Healthcare Pavilion | Louisville | Kentucky | 40202 | — |
| Norton Hospital | Louisville | Kentucky | 40202 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7600 | — |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | — |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | — |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | — |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | — |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | — |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | — |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | — |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02573259, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2021 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02573259 live on ClinicalTrials.gov.