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Taking people in United StatesPhase 1

Tests mevrometostat with enzalutamide in men with castration resistant prostate cancer

Tests mevrometostat, alone or with enzalutamide, in men whose prostate cancer kept growing after treatment.

Key facts

Who runs it
Pfizer
Where
Anaheim, Austin, Boston, Dallas, Duarte, Fairfax, Fairway, Hackensack, Irving, Kansas City, Louisville, Myrtle Beach, Nashville, Newton, Norwalk, Oklahoma City, Omaha, Overland Park, Port Angeles, Poulsbo, Rockville, San Antonio, Seattle, Tucson, and Westwood, United StatesSee the 44 sitesAlso in 7 other countries, 43 sites
Registry title
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Status
Recruiting
Phase
Phase 1
People taking part
453 people, planned
Started
17 Apr 2018
Expected to end
7 Jul 2029
Type of study
Interventional, 10 groups
Treatments tested
  • Mevrometostat (PF-06821497)
  • Enzalutamide
  • Itraconazole
Record updated
15 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The open part of this trial (Part 3) is looking for adults with castration resistant prostate cancer who were treated before and whose cancer got worse after the last treatment.

Age
18 years or older
Sex
All sexes are listed in the record, but Part 3 is looking for men.
Disease stage
Castration resistant prostate cancer confirmed by tissue or cell tests; ECOG performance status 0-2; expected life expectancy of at least 6 months.
Earlier treatment
Must have had treatment for castration resistant prostate cancer before, with the cancer growing after the last treatment. Cannot have taken enzalutamide in the last 4 weeks.

Main reasons for not taking part

  • Earlier radiation to more than 25% of the bone marrow
  • QTcF heart interval above 480 msec at screening
  • High blood pressure not controlled by medicines (above 150/90 mmHg)
  • Allergy to PF 06821497 or enzalutamide
  • Active gut inflammation, chronic diarrhea or earlier stomach surgery

The registry criteria, word for word

Show all 16 criteriaShow less

Other criteria

  • 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

Where in United States

Also in 7 other countries, 43 sites

  • Pacific Cancer Medical Center INCAnaheim, United StatesNo longer taking part
  • Texas Oncology-Austin MidtownAustin, United StatesNo longer taking part
  • Brigham and Women's HospitalBoston, United StatesNo longer taking part
  • Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
  • University of Texas Southwestern Medical Center - Simmons Cancer CenterDallas, United StatesNo longer taking part
  • UT Southwestern Medical CenterDallas, United StatesNo longer taking part
  • UT Southwestern University Hospital - William P. Clements, JrDallas, United StatesNo longer taking part
  • UT Southwestern University Hospital - Zale LipshyDallas, United StatesNo longer taking part
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesNo longer taking part
  • City of Hope Investigational Drug Services (IDS)Duarte, United StatesNo longer taking part
  • Virginia Cancer Specialists PCFairfax, United StatesNo longer taking part
  • The University of Kansas - Clinical Research CenterFairway, United StatesNo longer taking part
  • The University of Kansas Cancer Center, Investigational Drug ServicesFairway, United StatesNo longer taking part
  • Hackensack University Medical CenterHackensack, United StatesNo longer taking part
  • John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesNo longer taking part
  • NEXT DallasIrving, United StatesTaking people
  • US Oncology Investigational Product Center (IPC)Irving, United StatesNo longer taking part
  • US Oncology Investigational Products CenterIrving, United StatesNo longer taking part
  • The University of Kansas HospitalKansas City, United StatesNo longer taking part
  • The University of Kansas Medical Center Medical Office BuildingKansas City, United StatesNo longer taking part
  • Norton Cancer Institute, DowntownLouisville, United StatesNo longer taking part
  • Norton Cancer Institute, Norton Healthcare PavilionLouisville, United StatesNo longer taking part
  • Norton HospitalLouisville, United StatesNo longer taking part
  • Carolina Urologic Research CenterMyrtle Beach, United StatesTaking people
  • Parkway Surgery CenterMyrtle Beach, United StatesTaking people
  • Sarah Cannon Research Institute- PharmacyNashville, United StatesTaking people
  • SCRI Oncology PartnersNashville, United StatesTaking people
  • Dana-Farber Cancer Institute - Chestnut HillNewton, United StatesNo longer taking part
  • Norwalk HospitalNorwalk, United StatesNo longer taking part
  • OU Health University of Oklahoma Medical CenterOklahoma City, United StatesTaking people
  • Stephenson Cancer Center (chemo location)Oklahoma City, United StatesTaking people
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, United StatesTaking people
  • The University of Kansas Cancer Center - Indian Creek CampusOverland Park, United StatesNo longer taking part
  • Olympic Medical CenterPort Angeles, United StatesNo longer taking part
  • Fred Hutchinson Cancer Center Alliance PeninsulaPoulsbo, United StatesNo longer taking part
  • Maryland Oncology Hematology, P.A.Rockville, United StatesNo longer taking part
  • NEXT OncologySan Antonio, United StatesTaking people
  • Fred Hutchinson Cancer CenterSeattle, United StatesNo longer taking part
  • University of Washington Medical CenterSeattle, United StatesNo longer taking part
  • Arizona Urology Specialists, PLLCTucson, United StatesNo longer taking part
  • Banner University Medical Center - TucsonTucson, United StatesNo longer taking part
  • The University of Arizona Cancer CenterTucson, United StatesNo longer taking part
  • The University of Arizona Cancer Center-North CampusTucson, United StatesNo longer taking part
  • The University of Kansas Cancer CenterWestwood, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 10 groups in the trial

  • Dose Escalation (Part 1A)Treatment being tested

    Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels

    Treatment: Mevrometostat (PF-06821497)

  • Dose Escalation (Part 1B)Treatment being tested

    Participants with FL will receive mevrometostat at escalating dose levels

    Treatment: Mevrometostat (PF-06821497)

  • Dose Escalation (Part 1C)Treatment being tested

    Participants with mCRPC will receive mevrometostat at escalating dose levels.

    Treatment: Mevrometostat (PF-06821497)

  • Dose Escalation (Part 2A)Treatment being tested

    Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.

    Treatment: Mevrometostat (PF-06821497) and Enzalutamide

  • Dose Expansion (Part 2B)Treatment being tested

    Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.

    Treatment: Mevrometostat (PF-06821497) and Enzalutamide

  • Japan CohortTreatment being tested

    Participants with CRPC will receive mevrometostat at one or two doses

    Treatment: Mevrometostat (PF-06821497)

  • China cohortTreatment being tested

    Participants will receive mevrometostat at one or two doses

    Treatment: Mevrometostat (PF-06821497)

  • Dose Expansion (Part 2C)Treatment being tested

    Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC

    Treatment: Mevrometostat (PF-06821497) and Enzalutamide

  • BE SubstudyTreatment being tested

    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.

    Treatment: Mevrometostat (PF-06821497) and Enzalutamide

  • DDI SubstudyTreatment being tested

    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.

    Treatment: Mevrometostat (PF-06821497), Enzalutamide, and Itraconazole

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests mevrometostat with enzalutamide in men with castration resistant prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 October 2026