Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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.
Study ID: NCT02573259
Study Description
Brief Summary: 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.
Detailed Description: Protocol B8011001 is a Phase 1, two part, open-label, multi center, multiple-dose, safety, efficacy, PK, and PD study of PF-06801591 administered intravenously (IV) or subcutaneous (SC) in previously treated adult patients with locally advanced or metastatic melanoma, squamous cell carcinoma head and neck (SCCHN), ovarian carcinoma, sarcoma, non-small cell lung carcinoma (NSCLC), urothelial carcinoma or other solid tumors. The first part of the study, Part 1 dose escalation, was designed to assess the safety and tolerability of increasing dose levels of IV or SC administered PF-06801591 to establish the maximum tolerated dose (MTD) using a modified Toxicity Probability Interval (mTPI) design. Part 2 expansion is designed to further evaluate the safety and efficacy of 300 mg of PF-06801591 administered SC once every 4 weeks in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose (RP2D). Part 1 enrollment has completed, enrollment will only be allowed for Part 2.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clinical Research Unit, Los Angeles, California, United States
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
Complex Oncology Center - Plovdiv EOOD, Plovdiv, , Bulgaria
"MHAT for Women Health - Nadezhda" OOD, Sofia, , Bulgaria
SHATOD "Dr. Marko Antonov Markov - Varna" EOOD, Varna, , Bulgaria
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Division of Medical Oncology, Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Hospital Sultan Ismail, Johor Bahru, Johor, Malaysia
University Malaya Medical Centre, Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia
Clinical Research Centre(Crc), Hospital Umum Sarawak, Kuching, Sarawak, Malaysia
Szpitale Pomorskie Sp. z.o.o., Oddzial Onkologii i Radioterapii, Gdynia, , Poland
Regionalny Szpital Specjalistyczny im. dr. Wl. Bieganskiego w Grudziadzu, Grudziadz, , Poland
Centrum Badan Klinicznych JCI Life Science Park, Krakow, , Poland
Mazowiecki Szpital Specjalistyczny im. Dr. Jozefa Psarskiego w Ostrolece, Osrodek Onkologiczny, Ostroleka, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Otwock, , Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warszawa, , Poland
Sbhi "Lrcod", Vsevolozhsky District, Leningrad Region, Russian Federation
SBHI ¨Saint-Petersburg clinical scientific practical center of specialized types of, Pesochny Village, Saint-petersburg, Russian Federation
SBHI "ChRCCO and NM", Chelyabinsk, , Russian Federation
MROI n.a. P.A. Gertsen, filiation of FSBI "NMRC of radiology" MoH Russia, Moscow, , Russian Federation
BHI of Omsk Region "Clinical Oncology Dispensary", Omsk, , Russian Federation
Joint Stock Company Current medical technologies, Saint-Petersburg, , Russian Federation
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨, Saint-Petersburg, , Russian Federation
SPb SBHI "City Clinical Oncology Dispensary", Saint-Petersburg, , Russian Federation
SPb SBHI "City Clinical Oncology Dispensary", Saint-Petersburg, , Russian Federation
Joint-Stock Company Current medical technologies, St. Petersburg, , Russian Federation
SBHI YaR ¨Regional clinical oncology hospital¨, Yaroslavl, , Russian Federation
Communal Non-profit Institution "City Clinical Hospital #4" of Dnipro City Council, Department of, Dnipro, , Ukraine
Communal non-Commercial Enterprise "Prykarpatski Clinical Oncological Center of Ivano-, Ivano-Frankivsk, , Ukraine
Grigoriev Radiological Institute of the National Academy of Medical Sciences of Ukraine,, Kharkiv, , Ukraine
Communal Non-profit Institution of Kharkiv Regional Council "Regional Clinical Specialized Health, Kharkiv, , Ukraine
"Specialized Clinic "Prognosis Optima" LLC, Kyiv, , Ukraine
Communal noncommercial enterprise Sumy regional Rada Sumy regional clinical oncologic dispensary,, Sumy, , Ukraine
Communal Non-profit Institution "Central City Clinical Hospital" of Uzhhorod City Council,, Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Oncological Hospital, Vinnytsia, , Ukraine
Communal Institution ¨Zaporizhzhya Regional Clinical Oncological Dispensary¨, Zaporizhzhya, , Ukraine
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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