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

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer (SCLC); Follicular Lymphoma (FL); Castration Resistant Prostate Cancer (CRPC)
• Intervention / Treatment: Drug: PF-06821497

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.

• Study Type: Interventional
• Enrollment (Estimated): 267
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Bulgaria
  • Haskovo, Bulgaria, 6300
    • Not yet recruiting
    • Specialized Hospital for Active Treatment of Oncology - Haskovo
  • Plovdiv, Bulgaria, 4004
    • Not yet recruiting
    • Complex Oncology Center - Plovdiv EOOD
  • Ruse, Bulgaria, 7002
    • Recruiting
    • Complex Oncology Center - Ruse EOOD
  • Vratsa, Bulgaria, 3000
    • Not yet recruiting
    • "Complex Oncology Center - Vratsa" EOOD
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210008
      • Not yet recruiting
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Sichuan
    • Cheng Du, Sichuan, China, 610041
      • Not yet recruiting
      • West China Hospital, Sichuan University
    • Cheng Du, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Japan
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
• Korea, Republic of
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, Korea, Republic of, 10408
      • Recruiting
      • National Cancer Center
    • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul-teukbyeolsi [seoul]
    • Gangnam-gu, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06273
      • Recruiting
      • Gangnam Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06351
      • Recruiting
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722
      • Recruiting
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 05505
      • Recruiting
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06273
      • Recruiting
      • Gangnam Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 07985
      • Recruiting
      • Ewha Womans University Mokdong Hospital
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, Korea, Republic of, 41404
      • Recruiting
      • Kyungpook National University Chilgok Hospital
  • Taejǒn-kwangyǒkshi
    • Daejeon, Taejǒn-kwangyǒkshi, Korea, Republic of, 35015
      • Recruiting
      • Chungnam National University Hospital
• Poland
  • Koszalin, Poland, 75-581
    • Recruiting
    • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
  • Koszalin, Poland, 75-900
    • Recruiting
    • Centrum Diagnostyczne Affidea Koszalin
  • Rzeszow, Poland, 35-326
    • Not yet recruiting
    • Centrum Medyczne Medyk
  • Rzeszow, Poland, 35-326
    • Recruiting
    • Centrum Medyczne Medyk
  • Warszawa, Poland, 02-781
    • Recruiting
    • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  • Warszawa, Poland, 01-748
    • Not yet recruiting
    • LUX MED Onkologia Sp. z o.o. Szpital Szamocka
• Russian Federation
  • Moscow, Russian Federation, 117186
    • Active, not recruiting
    • LLC "Neyro-klinika"
  • Moscow, Russian Federation, 129301
    • Active, not recruiting
    • SBHI of Moscow City Clinical Hospital
  • Moscow, Russian Federation, 125284
    • Terminated
    • Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
  • Omsk, Russian Federation, 644013
    • Terminated
    • Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
  • Saint Petersburg, Russian Federation, 197341
    • Active, not recruiting
    • Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
  • Saint Petersburg, Russian Federation, 198255
    • Terminated
    • Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
  • Saint-Petersburg, Russian Federation, 195271
    • Active, not recruiting
    • Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
  • Saint-Petersburg, Russian Federation, 195271
    • Active, not recruiting
    • Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
  • Saint-Petersburg, Russian Federation, 197758
    • Terminated
    • Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
  • Yaroslavl, Russian Federation, 150054
    • Terminated
    • State Budgetary Healthcare Institution of the Yaroslavl Region
  • Saint - Petersburg
    • Pushkin, Saint - Petersburg, Russian Federation, 196603
      • Active, not recruiting
      • Private medical institution "Euromedservice"
  • Saint Petersburg
    • Pushkin, Saint Petersburg, Russian Federation, 196603
      • Active, not recruiting
      • Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
  • Saint-petersburg
    • Pushkin, Saint-petersburg, Russian Federation, 196603
      • Active, not recruiting
      • Private medical institution "Euromedservice"
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08023
    • Not yet recruiting
    • Hospital Hm Nou Delfos
  • Barcelona, Spain, 08041
    • Not yet recruiting
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08023
    • Not yet recruiting
    • Hospital Quironsalud Barcelona
  • Castellon, Spain, 12002
    • Recruiting
    • Consorcio Hospitalario Provincial de Castellón
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario HM Sanchinarro
  • Madrid, Spain, 28040
    • Recruiting
    • H.U. Fundación Jiménez Díaz
  • Malaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Virgen de la Victoria
  • València, Spain, 46026
    • Recruiting
    • Hospital Universitari I Politecnic La Fe
  • Barecelona
    • L'Hospitalet de Llobregat, Barecelona, Spain, 08908
      • Recruiting
      • Institut Català d´Oncología (ICO)-H. Durán i Reynals
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Recruiting
      • Hospital Quirónsalud Madrid
• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Recruiting
      • Urological Associates of Southern Arizona, P.C .
    • Tucson, Arizona, United States, 85719
      • Active, not recruiting
      • Banner-University Medical Center Tucson
    • Tucson, Arizona, United States, 85719
      • Active, not recruiting
      • The University of Arizona Cancer Center-North Campus
    • Tucson, Arizona, United States, 85724-5024
      • Active, not recruiting
      • The University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85741
      • Recruiting
      • Urological Associates of Southern Arizona, PC
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • Pacific Cancer Medical Center Inc
    • Duarte, California, United States, 91010
      • Active, not recruiting
      • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    • Duarte, California, United States, 91010
      • Active, not recruiting
      • City of Hope Investigational Drug Services (IDS)
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Recruiting
      • Norwalk Hospital
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Recruiting
      • Illinois CancerCare, P.C.
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Active, not recruiting
      • The University of Kansas Cancer Center, Investigational Drug Services
    • Fairway, Kansas, United States, 66205
      • Active, not recruiting
      • The University of Kansas Clinical Research Center
    • Kansas City, Kansas, United States, 66160
      • Active, not recruiting
      • The University of Kansas Hospital
    • Kansas City, Kansas, United States, 66160
      • Active, not recruiting
      • The University of Kansas Medical Center Medical Office Building
    • Overland Park, Kansas, United States, 66211
      • Active, not recruiting
      • The University of Kansas Cancer Center - Indian Creek Campus
    • Westwood, Kansas, United States, 66205
      • Active, not recruiting
      • The University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Active, not recruiting
      • Norton Cancer Institute Pharmacy, Downtown Pharmacy
    • Louisville, Kentucky, United States, 40202
      • Active, not recruiting
      • Norton Cancer Institute Pharmacy
    • Louisville, Kentucky, United States, 40202
      • Active, not recruiting
      • Norton Cancer Institute, Norton Healthcare Pavilion
    • Louisville, Kentucky, United States, 40202
      • Active, not recruiting
      • Norton Hospital
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Terminated
      • Maryland Oncology Hematology, P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Active, not recruiting
      • Hackensack University Medical Center
    • Hackensack, New Jersey, United States, 07601
      • Active, not recruiting
      • John Theurer Cancer Center at Hackensack University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Stephenson Cancer Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • OU Medical Center Presbyterian Tower
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Parkway Surgery Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • The Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncolgy, PLLC
  • Texas
    • Austin, Texas, United States, 78705
      • Terminated
      • Texas Oncology - Austin Midtown
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center - Simmons Cancer Center
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Simmons Cancer Center
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern University Hospital - William P. Clements, Jr
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern University Hospital - Zale Lipshy
    • Fort Worth, Texas, United States, 76104
      • Not yet recruiting
      • Texas Oncology -Fort Worth Cancer Center
    • Irving, Texas, United States, 75063
      • Not yet recruiting
      • US Oncology Investigational Product Center (IPC)
    • Irving, Texas, United States, 75063
      • Terminated
      • US Oncology Investigational Product Center (IPC)
    • Irving, Texas, United States, 75063
      • Terminated
      • US Oncology Investigational Products Center
    • San Antonio, Texas, United States, 78240
      • Active, not recruiting
      • NEXT Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists, PC
    • Norfolk, Virginia, United States, 23502
      • Not yet recruiting
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation (Part 1A); Participants with SCLC, CRPC and FL will receive PF-06821497 at escalating dose levels	Drug: PF-06821497; Oral continuous; Other Names: EZH2i
Experimental: Dose Escalation (Part 1B); Participants with FL will receive PF-06821497 at escalating dose levels	Drug: PF-06821497; Oral continuous; Other Names: EZH2i
Experimental: Dose Escalation (Part 1C); Participants with CRPC will receive PF-06821497 at escalating dose levels.	Drug: PF-06821497; Oral continuous; Other Names: EZH2i
Experimental: Dose Escalation (Part 2A); Participants with CRPC and SCLC will receive PF-06821497 at escalating dose levels in combination with SOC.	Drug: PF-06821497; Oral continuous; Other Names: EZH2i
Experimental: Dose Expansion (Part 2B); Participants with CRPC will receive PF-06821497 in combination with SOC or SOC alone.	Drug: PF-06821497; Oral continuous; Other Names: EZH2i
Experimental: Japan Cohort; Participants with CRPC will receive PF-06821497 at one or two doses	Drug: PF-06821497; Oral continuous; Other Names: EZH2i
Experimental: China cohort; Participants will receive PF-06821497 at one or two doses	Drug: PF-06821497; Oral continuous; Other Names: EZH2i

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline up to 90 days
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])	Baseline up to approximately 2 years
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.	Through study completion, approximately 2 years past last patient first visit.
Overall safety profile including laboratory abnormalities	Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version [4.03]), and timing.	Baseline up to approximately 2 years
Overall safety profile including vital signs	Vital sign changes from baseline including blood pressure, heart rate, ECG changes.	Baseline up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
Evaluate overall survival	Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.	Baseline up to approximately 2 years
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)	Single dose and multiple dose PK will be calculated as data permits	At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)	Single dose and multiple dose PK will be calculated as data permits	At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Area Under the Curve (AUC)	Single dose and multiple dose PK will be calculated as data permits	At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F)	Single dose and multiple dose PK will be calculated as data permits	At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F)	Single dose and multiple dose PK will be calculated as data permits	At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2)	Singe dose and multiple dose PK will be calculated as data permits	At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Evaluate the impact of PF-06821497 on patient reported outcomes.	Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P.	At specific time-points from Cycle 1 Day 1 to End of Treatment visit.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Estimated): October 24, 2025
• Study Completion (Estimated): October 24, 2025

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics; open-label; efficacy; pharmacodynamics; FL; relapsed; refractory; small cell lung cancer; CRPC; dose escalation; SCLC; follicular lymphoma; dose expansion; EZH2; castrate resistant prostate cancer; enhancer of zeste homolog 2; prostatecancer-study.com
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Lymphoma; Lymphoma, Follicular; Prostatic Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: C2321001; 2018-001835-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No