A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Recruiting · NCT03460977 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
60 locations listed across 15 US states.
- Banner-University Medical Center Tucson - Tucson, Arizona, United States
- The University of Arizona Cancer Center-North Campus - Tucson, Arizona, United States
- The University of Arizona Cancer Center - Tucson, Arizona, United States
- Arizona Urology Specialists, PLLC - Tucson, Arizona, United States
- Pacific Cancer Medical Center INC - Anaheim, California, United States
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) - Duarte, California, United States
- City of Hope Investigational Drug Services (IDS) - Duarte, California, United States
- Norwalk Hospital - Norwalk, Connecticut, United States
- The University of Kansas Cancer Center, Investigational Drug Services - Fairway, Kansas, United States
- The University of Kansas Clinical Research Center - Fairway, Kansas, United States
- The University of Kansas Hospital - Kansas City, Kansas, United States
- The University of Kansas Medical Center Medical Office Building - Kansas City, Kansas, United States
- The University of Kansas Cancer Center - Indian Creek Campus - Overland Park, Kansas, United States
- The University of Kansas Cancer Center - Westwood, Kansas, United States
- Norton Cancer Institute - Downtown - Louisville, Kentucky, United States
- Norton Cancer Institute, Norton Healthcare Pavilion - Louisville, Kentucky, United States
- Norton Hospital - Louisville, Kentucky, United States
- Maryland Oncology Hematology, P.A. - Rockville, Maryland, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Dana Farber Cancer Institute- Chestnut Hill - Newton, Massachusetts, United States
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey, United States
- OU Health University of Oklahoma Medical Center - Oklahoma City, Oklahoma, United States
- Stephenson Cancer Center (chemo location) - Oklahoma City, Oklahoma, United States
- Carolina Urologic Research Center - Myrtle Beach, South Carolina, United States
- Parkway Surgery Center - Myrtle Beach, South Carolina, United States
- Sarah Cannon Research Institute - Pharmacy - Nashville, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Texas Oncology - Austin Midtown - Austin, Texas, United States
- University of Texas Southwestern Medical Center - Simmons Cancer Center - Dallas, Texas, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
- UT Southwestern University Hospital - William P. Clements, Jr - Dallas, Texas, United States
- UT Southwestern University Hospital - Zale Lipshy - Dallas, Texas, United States
- NEXT Dallas - Irving, Texas, United States
- US Oncology Investigational Product Center (IPC) - Irving, Texas, United States
- US Oncology Investigational Products Center - Irving, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- Virginia Cancer Specialists, PC - Fairfax, Virginia, United States
- Olympic Medical Center - Port Angeles, Washington, United States
- Fred Hutchinson Cancer Center Alliance Peninsula - Poulsbo, Washington, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- University of Washington Medical Center - Seattle, Washington, United States
- Hospital Quironsalud Barcelona - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- In-Vivo Sp. z o.o. In-vivo Bydgoszcz - Bydgoszcz, Poland
- Specialized Hospital for Active Treatment of Oncology - Haskovo - Haskovo, Bulgaria
- Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie - Koszalin, Poland
- Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o. - Krakow, Poland
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- H.U. Fundación Jiménez Díaz - Madrid, Spain
- Hospital Clinico San Carlos - Madrid, Spain
- Hospital Universitario 12 De Octubre - Madrid, Spain
- Hospital Universitario HM Sanchinarro - Madrid, Spain
- LLC "Neyro-klinika" - Moscow, Russia
- Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department - Moscow, Russia
- SBHI of Moscow City Clinical Hospital - Moscow, Russia
- Hospital Universitario Virgen de la Victoria - Málaga, Spain
Showing 60 of 84 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →