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PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Primary Purpose

Castration Resistant Prostate Cancer (CRPC), Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL)

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-06821497
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration Resistant Prostate Cancer (CRPC) focused on measuring EZH2, enhancer of zeste homolog 2, castrate resistant prostate cancer, prostatecancer-study.com, CRPC, efficacy, safety, pharmacokinetics, pharmacodynamics, dose escalation, dose expansion, open-label, small cell lung cancer, SCLC, follicular lymphoma, FL, relapsed, refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts:

Part 1A (closed to enrollment):

Part 1B (closed to enrollment):

Part 1C:

• Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)

Part 2A:

• Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have evidence of prostate cancer progression (per PCWG3)

Part 2B:

  • Castration resistant prostate cancer. Patients should have received abiraterone treatment, may have received up to 1 prior line of chemotherapy, have not received prior enzalutamide, and have evidence of prostate cancer progression (per PCWG3)
  • Patients must have radiographic evidence of disease

Other inclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Adequate organ function

Key Exclusion Criteria:

- Prior Chemotherapy: Part 1C (CRPC): no more than 2 previous regimens of chemotherapy Part 2A: CRPC: no more than 1 previous regimen of systemic chemotherapy Part 2B (CRPC): no more than 1 previous regimen of chemotherapy

  • Prior irradiation to >25% of the bone marrow.
  • QTcF interval >480 msec at screening.
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers or inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.

Sites / Locations

  • Urological Associates of Southern Arizona, P.C .Recruiting
  • Banner-University Medical Center Tucson
  • The University of Arizona Cancer Center-North Campus
  • The University of Arizona Cancer Center
  • Urological Associates of Southern Arizona, PCRecruiting
  • Pacific Cancer Medical Center INCRecruiting
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
  • City of Hope Investigational Drug Services (IDS)
  • Norwalk HospitalRecruiting
  • Illinois CancerCare, P.C.Recruiting
  • The University of Kansas Cancer Center, Investigational Drug Services
  • The University of Kansas Clinical Research Center
  • The University of Kansas Hospital
  • The University of Kansas Medical Center Medical Office Building
  • The University of Kansas Cancer Center - Indian Creek Campus
  • The University of Kansas Cancer Center
  • Norton Cancer Institute Pharmacy, Downtown Pharmacy
  • Norton Cancer Institute Pharmacy
  • Norton Cancer Institute, Norton Healthcare Pavilion
  • Norton Hospital
  • Maryland Oncology Hematology, P.A.
  • Brigham and Women's HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsRecruiting
  • Hackensack University Medical CenterRecruiting
  • John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
  • OU Medical Center Presbyterian TowerRecruiting
  • Stephenson Cancer CenterRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Parkway Surgery CenterRecruiting
  • Tennessee Oncolgy, PLLCRecruiting
  • Tennessee Oncology, PLLCRecruiting
  • The Sarah Cannon Research InstituteRecruiting
  • Texas Oncology - Austin Midtown
  • University of Texas Southwestern Medical Center - Simmons Cancer CenterRecruiting
  • University of Texas Southwestern Medical Center-Simmons Cancer Center PharmacyRecruiting
  • UT Southwestern Medical CenterRecruiting
  • UT Southwestern Simmons Cancer CenterRecruiting
  • UT Southwestern University Hospital - William P. Clements, JrRecruiting
  • UT Southwestern University Hospital - Zale LipshyRecruiting
  • Texas Oncology -Fort Worth Cancer Center
  • US Oncology Investigational Product Center (IPC)
  • US Oncology Investigational Product Center (IPC)
  • US Oncology Investigational Products Center
  • NEXT Oncology
  • Virginia Cancer Specialists, PCRecruiting
  • Virginia Oncology Associates
  • Seattle Cancer Care AllianceRecruiting
  • Specialized Hospital for Active Treatment of Oncology - Haskovo
  • Complex Oncology Center - Ruse EOODRecruiting
  • "Complex Oncology Center - Vratsa" EOOD
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Hunan Cancer HospitalRecruiting
  • Zhongda Hospital Southeast UniversityRecruiting
  • West China Hospital, Sichuan University
  • West China Hospital, Sichuan UniversityRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • National Cancer Center Hospital EastRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • Samsung Medical CenterRecruiting
  • Ewha Womans University Mokdong HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Chungnam national university hospitalRecruiting
  • Centrum Medyczne MEDYK
  • Centrum Medyczne MEDYKRecruiting
  • LUX MED Onkologia Sp. z o.o. Szpital Szamocka
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w WarszawieRecruiting
  • Private Medical Institution "Euromedservice"
  • Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
  • Private medical institution "Euromedservice"
  • LLC "Neyro-klinika"
  • Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
  • SBHI of Moscow City Clinical Hospital
  • Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
  • Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
  • Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
  • Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
  • Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
  • Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
  • State Budgetary Healthcare Institution of the Yaroslavl Region
  • Institut Català d´Oncología (ICO)-H. Durán i ReynalsRecruiting
  • Hospital HM Nou Delfos
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital de la Santa Creu i Sant Pau
  • Consorcio Hospitalario Provincial de CastellonRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • H.U. Fundación Jiménez DíazRecruiting
  • Hospital Universitario 12 De OctubreRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation (Part 1A)

Dose Escalation (Part 1B)

Dose Escalation (Part 1C)

Dose Escalation (Part 2A)

Dose Expansion (Part 2B)

Japan Cohort

China cohort

Arm Description

Participants with SCLC, CRPC and FL will receive PF-06821497 at escalating dose levels

Participants with FL will receive PF-06821497 at escalating dose levels

Participants with CRPC will receive PF-06821497 at escalating dose levels.

Participants with CRPC and SCLC will receive PF-06821497 at escalating dose levels in combination with SOC.

Participants with CRPC will receive PF-06821497 in combination with SOC or SOC alone.

Participants with CRPC will receive PF-06821497 at one or two doses

Participants will receive PF-06821497 at one or two doses

Outcomes

Primary Outcome Measures

Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
First cycle DLTs will be utilized to determine the MTD
Overall safety profile including adverse events
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [4.03])
Preliminary efficacy determination as evaluated by disease specific response criteria
Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.
Overall safety profile including laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version [4.03]), and timing.
Overall safety profile including vital signs
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.

Secondary Outcome Measures

Evaluate time to event anti-tumor activity of PF-06821497 including progression-free survival (PFS), PSA50, Duration of Response (DoR), Time to first skeletal related event and Time to symptomatic skeletal related event, depending on tumor type.
Time to event endpoints based on Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC)
Evaluate overall survival
Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Single dose and multiple dose PK will be calculated as data permits
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Single dose and multiple dose PK will be calculated as data permits
Pharmacokinetic Parameters: Area Under the Curve (AUC)
Single dose and multiple dose PK will be calculated as data permits
Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F)
Single dose and multiple dose PK will be calculated as data permits
Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F)
Single dose and multiple dose PK will be calculated as data permits
Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2)
Singe dose and multiple dose PK will be calculated as data permits
Evaluate the impact of PF-06821497 on patient reported outcomes.
Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P.

Full Information

First Posted
February 12, 2018
Last Updated
October 4, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03460977
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
October 24, 2025 (Anticipated)
Study Completion Date
October 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration Resistant Prostate Cancer (CRPC), Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL)
Keywords
EZH2, enhancer of zeste homolog 2, castrate resistant prostate cancer, prostatecancer-study.com, CRPC, efficacy, safety, pharmacokinetics, pharmacodynamics, dose escalation, dose expansion, open-label, small cell lung cancer, SCLC, follicular lymphoma, FL, relapsed, refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
267 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation (Part 1A)
Arm Type
Experimental
Arm Description
Participants with SCLC, CRPC and FL will receive PF-06821497 at escalating dose levels
Arm Title
Dose Escalation (Part 1B)
Arm Type
Experimental
Arm Description
Participants with FL will receive PF-06821497 at escalating dose levels
Arm Title
Dose Escalation (Part 1C)
Arm Type
Experimental
Arm Description
Participants with CRPC will receive PF-06821497 at escalating dose levels.
Arm Title
Dose Escalation (Part 2A)
Arm Type
Experimental
Arm Description
Participants with CRPC and SCLC will receive PF-06821497 at escalating dose levels in combination with SOC.
Arm Title
Dose Expansion (Part 2B)
Arm Type
Experimental
Arm Description
Participants with CRPC will receive PF-06821497 in combination with SOC or SOC alone.
Arm Title
Japan Cohort
Arm Type
Experimental
Arm Description
Participants with CRPC will receive PF-06821497 at one or two doses
Arm Title
China cohort
Arm Type
Experimental
Arm Description
Participants will receive PF-06821497 at one or two doses
Intervention Type
Drug
Intervention Name(s)
PF-06821497
Other Intervention Name(s)
EZH2i
Intervention Description
Oral continuous
Primary Outcome Measure Information:
Title
Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
Description
First cycle DLTs will be utilized to determine the MTD
Time Frame
Baseline up to 90 days
Title
Overall safety profile including adverse events
Description
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [4.03])
Time Frame
Baseline up to approximately 2 years
Title
Preliminary efficacy determination as evaluated by disease specific response criteria
Description
Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.
Time Frame
Through study completion, approximately 2 years past last patient first visit.
Title
Overall safety profile including laboratory abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version [4.03]), and timing.
Time Frame
Baseline up to approximately 2 years
Title
Overall safety profile including vital signs
Description
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.
Time Frame
Baseline up to approximately 2 years
Secondary Outcome Measure Information:
Title
Evaluate time to event anti-tumor activity of PF-06821497 including progression-free survival (PFS), PSA50, Duration of Response (DoR), Time to first skeletal related event and Time to symptomatic skeletal related event, depending on tumor type.
Description
Time to event endpoints based on Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC)
Time Frame
Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
Title
Evaluate overall survival
Description
Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.
Time Frame
Baseline up to approximately 2 years
Title
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Description
Single dose and multiple dose PK will be calculated as data permits
Time Frame
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Title
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
Single dose and multiple dose PK will be calculated as data permits
Time Frame
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Title
Pharmacokinetic Parameters: Area Under the Curve (AUC)
Description
Single dose and multiple dose PK will be calculated as data permits
Time Frame
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Title
Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F)
Description
Single dose and multiple dose PK will be calculated as data permits
Time Frame
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Title
Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F)
Description
Single dose and multiple dose PK will be calculated as data permits
Time Frame
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Title
Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2)
Description
Singe dose and multiple dose PK will be calculated as data permits
Time Frame
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Title
Evaluate the impact of PF-06821497 on patient reported outcomes.
Description
Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P.
Time Frame
At specific time-points from Cycle 1 Day 1 to End of Treatment visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts: Part 1A (closed to enrollment): Part 1B (closed to enrollment): Part 1C: Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) Japan cohort Castration resistant prostate cancer that is resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) China cohort Castration resistant prostate cancer that is intolerant/resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients who refused SOC may be eligible. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) Part 2A: • Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have evidence of prostate cancer progression (per PCWG3) Part 2B: Castration resistant prostate cancer. Patients should have received abiraterone treatment, may have received up to 1 prior line of chemotherapy, have not received prior enzalutamide, apalutamide or darolutamide and have evidence of prostate cancer progression (per PCWG3) Patients must have radiographic evidence of disease Other inclusion criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. Adequate organ function Key Exclusion Criteria: - Prior Chemotherapy: Part 1C , Japan cohort and China cohort (CRPC): no more than 2 previous regimens of chemotherapy Part 2A: CRPC: no more than 1 previous regimen of systemic chemotherapy Part 2B (CRPC): no more than 1 previous regimen of chemotherapy Prior irradiation to >25% of the bone marrow. QTcF interval >480 msec at screening. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy). Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC) Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed. Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers or inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Urological Associates of Southern Arizona, P.C .
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Name
Banner-University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Urological Associates of Southern Arizona, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Cancer Medical Center INC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
City of Hope Investigational Drug Services (IDS)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois CancerCare, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Kansas Cancer Center, Investigational Drug Services
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Kansas Clinical Research Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Kansas Medical Center Medical Office Building
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Kansas Cancer Center - Indian Creek Campus
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Cancer Institute Pharmacy, Downtown Pharmacy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Cancer Institute Pharmacy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Cancer Institute, Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Maryland Oncology Hematology, P.A.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Terminated
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
OU Medical Center Presbyterian Tower
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkway Surgery Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncolgy, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Terminated
Facility Name
University of Texas Southwestern Medical Center - Simmons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Simmons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern University Hospital - William P. Clements, Jr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern University Hospital - Zale Lipshy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology -Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
US Oncology Investigational Product Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Terminated
Facility Name
US Oncology Investigational Product Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
US Oncology Investigational Products Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Individual Site Status
Terminated
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Oncology - Haskovo
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Complex Oncology Center - Ruse EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
"Complex Oncology Center - Vratsa" EOOD
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Name
West China Hospital, Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
Taegu-kwangyǒkshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungnam national university hospital
City
Daejeon
State/Province
Taejǒn-kwangyǒkshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne MEDYK
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne MEDYK
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Individual Site Status
Recruiting
Facility Name
LUX MED Onkologia Sp. z o.o. Szpital Szamocka
City
Warszawa
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Private Medical Institution "Euromedservice"
City
Pushkin
State/Province
Saint - Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
City
Pushkin
State/Province
Saint Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Private medical institution "Euromedservice"
City
Pushkin
State/Province
Saint-petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
LLC "Neyro-klinika"
City
Moscow
ZIP/Postal Code
117186
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
SBHI of Moscow City Clinical Hospital
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
City
Saint-Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
City
Saint-Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
State Budgetary Healthcare Institution of the Yaroslavl Region
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Institut Català d´Oncología (ICO)-H. Durán i Reynals
City
L'Hospitalet de Llobregat
State/Province
Barecelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital HM Nou Delfos
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Consorcio Hospitalario Provincial de Castellon
City
Castellon
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
H.U. Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C2321001
Description
To obtain contact information for a study center near you, click here.
URL
https://www.pfizerclinicaltrials.com/nct03460977-metastatic-castration-resistant-prostate-cancer-trial
Description
To learn more about about prostatecancer-study, click here.

Learn more about this trial

PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

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