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

NCT03460977 · Pfizer
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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)
About this study
This is an open label, multi center, Phase 1 dose escalation and dose expansion study of mevrometostat (PF-06821497) administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. The study consists of three parts (Part 1, Part 2, and Part 3) along with the Japan and China monotherapy cohorts. Part 1 and Part 2 are closed for enrollment. Part 1 tested monotherapy in 3 cohorts (Parts 1A, 1B, and 1C); Part 2 tested combination therapy in Parts 2A (dose escalation), 2B and 2C (does expansion). Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body. The Sponsor may choose to delay or discontinue any cohorts or substudies.
Eligibility 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
Study design
Enrollment target: 453 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-04-17
Estimated completion: 2029-07-07
Last updated: 2026-04-16
Interventions
Drug: Mervometostat (PF-06821497)Drug: EnzalutamideDrug: Itraconazole
Primary outcomes
  • Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) (Baseline up to 90 days)
  • Overall safety profile including adverse events (Baseline up to approximately 2 years)
  • Preliminary efficacy determination as evaluated by disease specific response criteria (Through study completion, approximately 2 years past last patient first visit.)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (81)
Banner-University Medical Center TucsonActive Not Recruiting
Tucson, Arizona, United States
The University of Arizona Cancer Center-North CampusActive Not Recruiting
Tucson, Arizona, United States
The University of Arizona Cancer CenterActive Not Recruiting
Tucson, Arizona, United States
Arizona Urology Specialists, PLLCTerminated
Tucson, Arizona, United States
Pacific Cancer Medical Center INCActive Not Recruiting
Anaheim, California, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Active Not Recruiting
Duarte, California, United States
City of Hope Investigational Drug Services (IDS)Active Not Recruiting
Duarte, California, United States
Norwalk HospitalActive Not Recruiting
Norwalk, Connecticut, United States
The University of Kansas Cancer Center, Investigational Drug ServicesActive Not Recruiting
Fairway, Kansas, United States
The University of Kansas Clinical Research CenterActive Not Recruiting
Fairway, Kansas, United States
The University of Kansas HospitalActive Not Recruiting
Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office BuildingActive Not Recruiting
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Indian Creek CampusActive Not Recruiting
Overland Park, Kansas, United States
The University of Kansas Cancer CenterActive Not Recruiting
Westwood, Kansas, United States
Norton Cancer Institute Pharmacy, Downtown PharmacyActive Not Recruiting
Louisville, Kentucky, United States
Norton Cancer Institute PharmacyActive Not Recruiting
Louisville, Kentucky, United States
Norton Cancer Institute, Norton Healthcare PavilionActive Not Recruiting
Louisville, Kentucky, United States
Norton HospitalActive Not Recruiting
Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A.Terminated
Rockville, Maryland, United States
Brigham and Women's HospitalActive Not Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteActive Not Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer Institute- Chestnut HillActive Not Recruiting
Newton, Massachusetts, United States
Oncology Hematology West, PC dba Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Hackensack University Medical CenterActive Not Recruiting
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical CenterActive Not Recruiting
Hackensack, New Jersey, United States
OU Health University of Oklahoma Medical CenterRecruiting
Oklahoma City, Oklahoma, United States
Stephenson Cancer Center (chemo location)Recruiting
Oklahoma City, Oklahoma, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Parkway Surgery CenterRecruiting
Myrtle Beach, South Carolina, United States
Sarah Cannon Research Institute - PharmacyRecruiting
Nashville, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Austin MidtownTerminated
Austin, Texas, United States
University of Texas Southwestern Medical Center - Simmons Cancer CenterActive Not Recruiting
Dallas, Texas, United States
UT Southwestern Medical CenterActive Not Recruiting
Dallas, Texas, United States
UT Southwestern University Hospital - William P. Clements, JrActive Not Recruiting
Dallas, Texas, United States
UT Southwestern University Hospital - Zale LipshyActive Not Recruiting
Dallas, Texas, United States
US Oncology Investigational Product Center (IPC)Terminated
Irving, Texas, United States
US Oncology Investigational Products CenterTerminated
Irving, Texas, United States
NEXT OncologyActive Not Recruiting
San Antonio, Texas, United States
Virginia Cancer Specialists, PCActive Not Recruiting
Fairfax, Virginia, United States
Olympic Medical CenterRecruiting
Port Angeles, Washington, United States
Fred Hutchinson Cancer Center Alliance PeninsulaRecruiting
Poulsbo, Washington, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
Specialized Hospital for Active Treatment of Oncology - HaskovoTerminated
Haskovo, Bulgaria
The First Affiliated Hospital of Guangzhou Medical UniversityActive Not Recruiting
Guangzhou, Guangdong, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, Jiangsu, China
Zhongda Hospital Southeast UniversityRecruiting
Nanjing, Jiangsu, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical UniversityActive Not Recruiting
Wenzhou, Zhejiang, China
National Cancer Center Hospital EastActive Not Recruiting
Kashiwa, Chiba, Japan
Szpital Wojewódzki im. Mikołaja Kopernika w KoszalinieActive Not Recruiting
Koszalin, Poland
Centrum Medyczne MEDYKActive Not Recruiting
Rzeszów, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w WarszawieActive Not Recruiting
Warsaw, Poland
Private Medical Institution "Euromedservice"Active Not Recruiting
Pushkin, Sankt-Peterburg, Russia
LLC "Neyro-klinika"Active Not Recruiting
Moscow, Russia
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health departmentTerminated
Moscow, Russia
SBHI of Moscow City Clinical HospitalTerminated
Moscow, Russia
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"Terminated
Omsk, Russia
Federal State Budgetary Institution National Medical Research Center n.a. V.A. AlmazovTerminated
Saint Petersburg, Russia
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.Terminated
Saint Petersburg, Russia
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"Terminated
Saint Petersburg, Russia
State Budgetary Healthcare Institution of the Yaroslavl RegionTerminated
Yaroslavl, Russia
Seoul National University Bundang HospitalRecruiting
Seongnam, Kyǒnggi-do, South Korea
Seoul National University HospitalActive Not Recruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health SystemTerminated
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Ewha Womans University Mokdong HospitalActive Not Recruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Chungnam national university hospitalActive Not Recruiting
Daejeon, Taejǒn-kwangyǒkshi, South Korea
Institut Català d´Oncología (ICO)-H. Durán i ReynalsRecruiting
L'Hospitalet de Llobregat, Barecelona, Spain
Consorcio Hospitalario Provincial de CastellonActive Not Recruiting
Castellon, Castellon, Spain
Hospital Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Quironsalud BarcelonaRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
H.U. Fundación Jiménez DíazRecruiting
Madrid, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Hospital Universitario HM SanchinarroRecruiting
Madrid, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma · TrialPath