Spots Global Cancer Trial Database for PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
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Trial Identification
Brief Title: PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Official Title: A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)
Study ID: NCT03460977
Interventions
Study Description
Brief Summary: A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).
Detailed Description: This is an open label, multi center, Phase 1 dose escalation and dose expansion study of PF-06821497 administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. Part 1A will evaluate safety and target modulation of PF-06821497 monotherapy in patients with SCLC, FL and CRPC. PF-06821497 will be administered as monotherapy in patients with FL in Part 1B dose escalation and to patients with CRPC in Part 1C dose escalation. For Part 2A (dose escalation combination therapy), PF-06821497 will be administered in combination with SOC in patients with CRPC and SCLC. For Part 2B (dose expansion), patients with mCRPC will be randomized (1:1 ratio) to receive either SOC or PF-06821497 in combination with SOC. Once safety and adequate target modulation has been established in Part 1A, Parts 1B and 2A of the trial will be initiated. Part 1C (monotherapy dose escalation) will determine the MTD of single agent PF-06821497 in patients with mCRPC. Japan and China monotherapy cohorts will evaluate the safety, antitumor activity and PK of single agent PF-06821497 in Japanese and Chinese patients. Part 2A (escalation RP2D finding for combination) will determine the MTD of the combination with SOC in patients with CRPC. Part 2B (dose expansion) will assess the efficacy of PF-06821497 at the RP2D in combination with SOC in patients with mCRPC in comparison to SOC alone. The study is currently enrolling Part 2B.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Urological Associates of Southern Arizona, P.C ., Tucson, Arizona, United States
Banner-University Medical Center Tucson, Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
The University of Arizona Cancer Center, Tucson, Arizona, United States
Urological Associates of Southern Arizona, PC, Tucson, Arizona, United States
Pacific Cancer Medical Center INC, Anaheim, California, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States
City of Hope Investigational Drug Services (IDS), Duarte, California, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Illinois CancerCare, P.C., Peoria, Illinois, United States
The University of Kansas Cancer Center, Investigational Drug Services, Fairway, Kansas, United States
The University of Kansas Clinical Research Center, Fairway, Kansas, United States
The University of Kansas Hospital, Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office Building, Kansas City, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus, Overland Park, Kansas, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy, Louisville, Kentucky, United States
Norton Cancer Institute Pharmacy, Louisville, Kentucky, United States
Norton Cancer Institute, Norton Healthcare Pavilion, Louisville, Kentucky, United States
Norton Hospital, Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A., Rockville, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
OU Medical Center Presbyterian Tower, Oklahoma City, Oklahoma, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Parkway Surgery Center, Myrtle Beach, South Carolina, United States
Tennessee Oncolgy, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center, Dallas, Texas, United States
University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
UT Southwestern Simmons Cancer Center, Dallas, Texas, United States
UT Southwestern University Hospital - William P. Clements, Jr, Dallas, Texas, United States
UT Southwestern University Hospital - Zale Lipshy, Dallas, Texas, United States
Texas Oncology -Fort Worth Cancer Center, Fort Worth, Texas, United States
US Oncology Investigational Product Center (IPC), Irving, Texas, United States
US Oncology Investigational Product Center (IPC), Irving, Texas, United States
US Oncology Investigational Products Center, Irving, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Specialized Hospital for Active Treatment of Oncology - Haskovo, Haskovo, , Bulgaria
Complex Oncology Center - Plovdiv EOOD, Plovdiv, , Bulgaria
Complex Oncology Center - Ruse EOOD, Ruse, , Bulgaria
"Complex Oncology Center - Vratsa" EOOD, Vratsa, , Bulgaria
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Hunan Cancer Hospital, Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
Zhongda Hospital Southeast University, Nanjing, Jiangsu, China
West China Hospital, Sichuan University, Cheng Du, Sichuan, China
West China Hospital, Sichuan University, Cheng Du, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Cancer Center, Goyang-si, Kyǒnggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Gangnam-gu, Seoul-teukbyeolsi [seoul], Korea, Republic of
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Asan Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, Taegu-kwangyǒkshi, Korea, Republic of
Chungnam national university hospital, Daejeon, Taejǒn-kwangyǒkshi, Korea, Republic of
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Koszalin, , Poland
Centrum Diagnostyczne Affidea Koszalin, Koszalin, , Poland
Centrum Medyczne MEDYK, Rzeszow, , Poland
Centrum Medyczne MEDYK, Rzeszow, , Poland
LUX MED Onkologia Sp. z o.o. Szpital Szamocka, Warszawa, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie, Warszawa, , Poland
Private Medical Institution "Euromedservice", Pushkin, Saint - Petersburg, Russian Federation
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg, Pushkin, Saint Petersburg, Russian Federation
Private medical institution "Euromedservice", Pushkin, Saint-petersburg, Russian Federation
LLC "Neyro-klinika", Moscow, , Russian Federation
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department, Moscow, , Russian Federation
SBHI of Moscow City Clinical Hospital, Moscow, , Russian Federation
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary", Omsk, , Russian Federation
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov, Saint Petersburg, , Russian Federation
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary", Saint Petersburg, , Russian Federation
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨, Saint-Petersburg, , Russian Federation
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg, Saint-Petersburg, , Russian Federation
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N., Saint-Petersburg, , Russian Federation
State Budgetary Healthcare Institution of the Yaroslavl Region, Yaroslavl, , Russian Federation
Institut Català d´Oncología (ICO)-H. Durán i Reynals, L'Hospitalet de Llobregat, Barecelona, Spain
Hospital Quironsalud Madrid, Pozuelo de Alarcon, Madrid, Spain
Hospital HM Nou Delfos, Barcelona, , Spain
Hospital Quironsalud Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Consorcio Hospitalario Provincial de Castellon, Castellon, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
H.U. Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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