Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT03460977

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

Led by Pfizer · Updated on 2026-05-05

453

Participants Needed

82

Research Sites

585 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological or cytological diagnosis of castration resistant prostate cancer
  • Eastern Cooperative Oncology Group Performance Status of 0 to 2
  • Expected life expectancy of at least 6 months
  • Adequate bone marrow, kidney, and liver function
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Prior radiation to more than 25% of bone marrow
  • QTcF interval greater than 480 milliseconds at screening
  • Uncontrolled high blood pressure above 150/90 mmHg despite medication
  • Known or suspected allergy to Mevrometostat or enzalutamide
  • Active inflammatory gastrointestinal disease, chronic diarrhea, diverticular disease, or past gastric surgery
  • Current or expected use of strong or moderate CYP3A4/5 inducers or inhibitors
  • Use of enzalutamide within the last 4 weeks
  • History of congestive heart failure or ventricular dysfunction (for DDI substudy)
  • Fructose intolerance (for DDI substudy)
  • Use of CYP3A4 substrates (for DDI substudy)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 82 locations

1

Banner-University Medical Center Tucson

Tucson, Arizona, United States, 85719

Active, Not Recruiting

2

The University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States, 85719

Active, Not Recruiting

3

The University of Arizona Cancer Center

Tucson, Arizona, United States, 85724

Active, Not Recruiting

4

Arizona Urology Specialists, PLLC

Tucson, Arizona, United States, 85741

Terminated

5

Pacific Cancer Medical Center INC

Anaheim, California, United States, 92801

Active, Not Recruiting

6

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States, 91010

Active, Not Recruiting

7

City of Hope Investigational Drug Services (IDS)

Duarte, California, United States, 91010

Active, Not Recruiting

8

Norwalk Hospital

Norwalk, Connecticut, United States, 06856

Active, Not Recruiting

9

The University of Kansas Cancer Center, Investigational Drug Services

Fairway, Kansas, United States, 66205

Active, Not Recruiting

10

The University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

Active, Not Recruiting

11

The University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Active, Not Recruiting

12

The University of Kansas Medical Center Medical Office Building

Kansas City, Kansas, United States, 66160

Active, Not Recruiting

13

The University of Kansas Cancer Center - Indian Creek Campus

Overland Park, Kansas, United States, 66211

Active, Not Recruiting

14

The University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Active, Not Recruiting

15

Norton Cancer Institute Pharmacy, Downtown Pharmacy

Louisville, Kentucky, United States, 40202

Active, Not Recruiting

16

Norton Cancer Institute Pharmacy

Louisville, Kentucky, United States, 40202

Active, Not Recruiting

17

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, United States, 40202

Active, Not Recruiting

18

Norton Hospital

Louisville, Kentucky, United States, 40202

Active, Not Recruiting

19

Maryland Oncology Hematology, P.A.

Rockville, Maryland, United States, 20850

Terminated

20

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Active, Not Recruiting

21

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Active, Not Recruiting

22

Dana Farber Cancer Institute- Chestnut Hill

Newton, Massachusetts, United States, 02459

Active, Not Recruiting

23

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

Actively Recruiting

24

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Active, Not Recruiting

25

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Active, Not Recruiting

26

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

27

Stephenson Cancer Center (chemo location)

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

28

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

29

Parkway Surgery Center

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

30

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, United States, 37203

Actively Recruiting

31

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

32

Texas Oncology - Austin Midtown

Austin, Texas, United States, 78705

Terminated

33

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas, United States, 75390

Active, Not Recruiting

34

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Active, Not Recruiting

35

UT Southwestern University Hospital - William P. Clements, Jr

Dallas, Texas, United States, 75390

Active, Not Recruiting

36

UT Southwestern University Hospital - Zale Lipshy

Dallas, Texas, United States, 75390

Active, Not Recruiting

37

US Oncology Investigational Product Center (IPC)

Irving, Texas, United States, 75063

Terminated

38

US Oncology Investigational Products Center

Irving, Texas, United States, 75063

Terminated

39

NEXT Oncology

San Antonio, Texas, United States, 78229

Not Yet Recruiting

40

NEXT Oncology

San Antonio, Texas, United States, 78240

Active, Not Recruiting

41

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States, 22031

Active, Not Recruiting

42

Olympic Medical Center

Port Angeles, Washington, United States, 98362

Actively Recruiting

43

Fred Hutchinson Cancer Center Alliance Peninsula

Poulsbo, Washington, United States, 98370

Actively Recruiting

44

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

45

University of Washington Medical Center

Seattle, Washington, United States, 98109

Actively Recruiting

46

Specialized Hospital for Active Treatment of Oncology - Haskovo

Haskovo, Bulgaria, 6300

Terminated

47

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510120

Active, Not Recruiting

48

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

49

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210008

Actively Recruiting

50

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China, 210009

Actively Recruiting

51

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

52

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Active, Not Recruiting

53

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Active, Not Recruiting

54

Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

Koszalin, Poland, 75-581

Active, Not Recruiting

55

Centrum Medyczne MEDYK

Rzeszów, Poland, 35-326

Active, Not Recruiting

56

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Poland, 02-781

Active, Not Recruiting

57

Private Medical Institution "Euromedservice"

Pushkin, Sankt-Peterburg, Russia, 196603

Active, Not Recruiting

58

LLC "Neyro-klinika"

Moscow, Russia, 117186

Active, Not Recruiting

59

Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department

Moscow, Russia, 125284

Terminated

60

SBHI of Moscow City Clinical Hospital

Moscow, Russia, 129301

Terminated

61

Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"

Omsk, Russia, 644013

Terminated

62

Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov

Saint Petersburg, Russia, 197341

Terminated

63

Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.

Saint Petersburg, Russia, 197758

Terminated

64

Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"

Saint Petersburg, Russia, 198255

Terminated

65

State Budgetary Healthcare Institution of the Yaroslavl Region

Yaroslavl, Russia, 150054

Terminated

66

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea, 13620

Actively Recruiting

67

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080

Active, Not Recruiting

68

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722

Terminated

69

Ewha Womans University Mokdong Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea, 07985

Active, Not Recruiting

70

Chungnam national university hospital

Daejeon, Taejǒn-kwangyǒkshi, South Korea, 35015

Active, Not Recruiting

71

Institut Català d´Oncología (ICO)-H. Durán i Reynals

L'Hospitalet de Llobregat, Barecelona, Spain, 08908

Actively Recruiting

72

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, Spain, 12002

Active, Not Recruiting

73

Hospital Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain, 28223

Actively Recruiting

74

Hospital Quironsalud Barcelona

Barcelona, Spain, 08023

Actively Recruiting

75

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

76

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

77

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

78

H.U. Fundación Jiménez Díaz

Madrid, Spain, 28040

Actively Recruiting

79

Hospital Universitario 12 De Octubre

Madrid, Spain, 28041

Actively Recruiting

80

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

81

Hospital Universitario Virgen de la Victoria

Málaga, Spain, 29010

Actively Recruiting

82

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

10

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