A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Recruiting now · Phase 1
Conditions studied: Metastatic Castration Resistant Prostate Cancer (mCRPC), Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL)
In brief
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.
Key facts
- Study ID
- NCT03460977
- Run by
- Pfizer
- People needed
- 453
- Starts
- 2018-04-17
- Expected to finish
- 2029-07-07
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hospital Quironsalud Barcelona — Barcelona, Spain (enrolling)
- OU Health University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States (enrolling)
- Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
- Hospital Quironsalud Madrid — Pozuelo de Alarcón, Madrid, Spain (enrolling)
- H.U. Fundación Jiménez Díaz — Madrid, Spain (enrolling)
- Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)
- Parkway Surgery Center — Myrtle Beach, South Carolina, United States (enrolling)
- NEXT Dallas — Irving, Texas, United States (enrolling)
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (enrolling)
- Seoul National University Bundang Hospital — Seongnam, Kyǒnggi-do, South Korea (enrolling)
- Hospital Clinic de Barcelona — Barcelona, Spain (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario 12 De Octubre — Madrid, Spain (enrolling)
- Hospital Universitario HM Sanchinarro — Madrid, Spain (enrolling)
- Stephenson Cancer Center (chemo location) — Oklahoma City, Oklahoma, United States (enrolling)
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
- Sarah Cannon Research Institute - Pharmacy — Nashville, Tennessee, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (enrolling)
- Oncology Hematology West, PC dba Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
- Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o. — Krakow, Poland (enrolling)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
- Norton Cancer Institute - Downtown — Louisville, Kentucky, United States
- The University of Kansas Cancer Center — Westwood, Kansas, United States
Full record on ClinicalTrials.gov
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