Status:
RECRUITING
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Lead Sponsor:
Pfizer
Conditions:
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Small Cell Lung Cancer (SCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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), Castra...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- Part 1 and Part 2 (Closed for enrollment).
- Part 3 Key
- 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
- 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
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 14 2029
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT03460977
Start Date
April 17 2018
End Date
March 14 2029
Last Update
January 7 2026
Active Locations (83)
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1
Banner-University Medical Center Tucson
Tucson, Arizona, United States, 85719
2
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
3
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States, 85741