A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.

Part 3, which is open for enrollment is seeking men who:

• have Castration Resistant Prostate Cancer (CRPC) and
• have previously received treatment for CRPC and have progressed from the last treatment

All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).

In the assessment phase:

• participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods.
• participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and/or itraconazole 1 time a day based on a present schedule.
• participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule.

After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.

The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.

Study Overview

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

Detailed Description

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of mevrometostat (PF-06821497) administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. The study consists of three parts (Part 1, Part 2, and Part 3) along with the Japan and China monotherapy cohorts. Part 1 and Part 2 are closed for enrollment. Part 1 tested monotherapy in 3 cohorts (Parts 1A, 1B, and 1C); Part 2 tested combination therapy in Parts 2A (dose escalation), 2B and 2C (does expansion).

Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body. The Sponsor may choose to delay or discontinue any cohorts or substudies.

• Study Type: Interventional
• Enrollment (Estimated): 453
• 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
    • Terminated
    • Specialized Hospital for Active Treatment of Oncology - Haskovo
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Active, not 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
      • Recruiting
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Active, not recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Japan
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Active, not recruiting
      • National Cancer Center Hospital East
• Poland
  • Koszalin, Poland, 75-581
    • Active, not recruiting
    • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
  • Rzeszów, Poland, 35-326
    • Active, not recruiting
    • Centrum Medyczne Medyk
  • Warsaw, Poland, 02-781
    • Active, not recruiting
    • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
• Russia
  • Moscow, Russia, 117186
    • Active, not recruiting
    • LLC "Neyro-klinika"
  • Moscow, Russia, 125284
    • Terminated
    • Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
  • Moscow, Russia, 129301
    • Terminated
    • SBHI of Moscow City Clinical Hospital
  • Omsk, Russia, 644013
    • Terminated
    • Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
  • Saint Petersburg, Russia, 197341
    • Terminated
    • Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
  • Saint Petersburg, Russia, 197758
    • Terminated
    • Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
  • Saint Petersburg, Russia, 198255
    • Terminated
    • Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
  • Yaroslavl, Russia, 150054
    • Terminated
    • State Budgetary Healthcare Institution of the Yaroslavl Region
  • Sankt-Peterburg
    • Pushkin, Sankt-Peterburg, Russia, 196603
      • Active, not recruiting
      • Private Medical Institution "Euromedservice"
• South Korea
  • Kyǒnggi-do
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Active, not recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 07985
      • Active, not recruiting
      • Ewha Womans University Mokdong Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Terminated
      • Severance Hospital, Yonsei University Health System
  • Taejǒn-kwangyǒkshi
    • Daejeon, Taejǒn-kwangyǒkshi, South Korea, 35015
      • Active, not recruiting
      • Chungnam National University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08023
    • Recruiting
    • Hospital Quironsalud Barcelona
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramón 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
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Virgen de la Victoria
  • Valencia, 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
  • Castellon
    • Castellon, Castellon, Spain, 12002
      • Active, not recruiting
      • Consorcio Hospitalario Provincial de Castellon
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Recruiting
      • Hospital Quirónsalud Madrid
• United States
  • Arizona
    • 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
      • Active, not recruiting
      • The University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85741
      • Terminated
      • Arizona Urology Specialists, PLLC
  • California
    • Anaheim, California, United States, 92801
      • Active, not 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
      • Active, not recruiting
      • Norwalk Hospital
  • 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
      • Active, not recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Active, not recruiting
      • Dana Farber Cancer Institute
    • Newton, Massachusetts, United States, 02459
      • Active, not recruiting
      • Dana Farber Cancer Institute- Chestnut Hill
  • 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
      • OU Health University of Oklahoma Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Stephenson Cancer Center (chemo location)
  • 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
      • Sarah Cannon Research Institute - Pharmacy
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
  • Texas
    • Austin, Texas, United States, 78705
      • Terminated
      • Texas Oncology - Austin Midtown
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • University of Texas Southwestern Medical Center - Simmons Cancer Center
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern University Hospital - William P. Clements, Jr
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern University Hospital - Zale Lipshy
    • 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, 78229
      • Not yet recruiting
      • NEXT Oncology
    • San Antonio, Texas, United States, 78240
      • Active, not recruiting
      • NEXT Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Active, not recruiting
      • Virginia Cancer Specialists, PC
  • Washington
    • Port Angeles, Washington, United States, 98362
      • Recruiting
      • Olympic Medical Center
    • Poulsbo, Washington, United States, 98370
      • Recruiting
      • Fred Hutchinson Cancer Center Alliance Peninsula
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Part 1 and Part 2 (Closed for enrollment).

Part 3 Key Inclusion Criteria:

• Histological or cytological diagnosis of castration resistant prostate cancer.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.
• Adequate bone marrow, renal, and liver function

Part 3 Key Exclusion Criteria:

• 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.
• Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4/5 inducers or inhibitors
• Prior enzalutamide within the last 4 weeks
• DDI SUBSTUDY:
• history of CHF or evidence of ventricular dysfunction
• fructose intolerance
• coadministration of CYP3A4 substrates

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

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation (Part 1A); Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i
Experimental: Dose Escalation (Part 1B); Participants with FL will receive mevrometostat at escalating dose levels	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i
Experimental: Dose Escalation (Part 2A); Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i; Drug: Enzalutamide; Oral continuous; Other Names: Xtandi
Experimental: Dose Expansion (Part 2B); Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i; Drug: Enzalutamide; Oral continuous; Other Names: Xtandi
Experimental: Japan Cohort; Participants with CRPC will receive mevrometostat at one or two doses	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i
Experimental: China cohort; Participants will receive mevrometostat at one or two doses	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i
Experimental: Dose Expansion (Part 2C); Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i; Drug: Enzalutamide; Oral continuous; Other Names: Xtandi
Experimental: BE Substudy; In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i; Drug: Enzalutamide; Oral continuous; Other Names: Xtandi
Experimental: Dose Escalation (Part 1C); Participants with mCRPC will receive mevrometostat at escalating dose levels.	Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i
Experimental: DDI Substudy; The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.	Drug: Itraconazole; Oral solution; Other Names: Sporanox; Tolsura; Onmel; Drug: Mervometostat (PF-06821497); Oral continuous; Other Names: EZH2i; Drug: Enzalutamide; Oral continuous; Other Names: Xtandi

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
Evaluate time to event mevrometostat and enzalutamide vs enzalutamide alone including radiographic prgression free survival	PCWG3	Baseline until disease progression or death or through study completion (approx 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 time to event anti-tumor activity of mevrometostat 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 the impact of mevrometostat 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.
Impact of mevrometostat in combination with enzalutamide, enzalutamide alone and mevrometostat alone on symptoms and symptomatic toxicity	Questionnaire customized from PRO-CTCAE.	At specific time points from Cycle1 Day 1 to end of treatment

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): April 20, 2028
• Study Completion (Estimated): July 7, 2029

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): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics; open-label; efficacy; mCRPC; pharmacodynamics; FL; relapsed; refractory; small cell lung cancer; dose escalation; SCLC; follicular lymphoma; dose expansion; EZH2; castrate resistant prostate cancer; enhancer of zeste homolog 2; prostatecancer-study.com
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Small Cell Lung Carcinoma; Lymphoma, Follicular; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Piperazines; Itraconazole; enzalutamide; PF06821497
• Other Study ID Numbers: C2321001; 2023-509179-18-00 (Registry Identifier: CTIS (EU)); EZH2 (Other Identifier: Alias Study 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