RECRUITING

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

Description

A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 (Mevrometostat) in Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).

Study Overview

Study Details

Study overview

A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 (Mevrometostat) in Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).

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)

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

Condition
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Intervention / Treatment

-

Contacts and Locations

Tucson

Urological Associates of Southern Arizona, P.C ., Tucson, Arizona, United States, 85715

Tucson

Banner-University Medical Center Tucson, Tucson, Arizona, United States, 85719

Tucson

The University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States, 85719

Tucson

The University of Arizona Cancer Center, Tucson, Arizona, United States, 85724-5024

Tucson

Urological Associates of Southern Arizona, PC, Tucson, Arizona, United States, 85741

Anaheim

Pacific Cancer Medical Center INC, Anaheim, California, United States, 92801

Duarte

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States, 91010

Duarte

City of Hope Investigational Drug Services (IDS), Duarte, California, United States, 91010

Norwalk

Norwalk Hospital, Norwalk, Connecticut, United States, 06856

Peoria

Illinois CancerCare, P.C., Peoria, Illinois, United States, 61615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Metastatic 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)
  • * Metastatic 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2025-12-09