Clinical trial for Metastatic Castration Resistant Prostate Cancer (mCRPC)
Official title A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
ClinicalTrials.gov ID: NCT03460977
What this study is testing
What is Mevrometostat?
This is an investigational oral medicine being studied as a potential treatment for metastatic castration-resistant prostate cancer. It is designed to block an enzyme called EZH2, which helps control how genes are turned on or off in cells.
Also referred to as PF-06821497.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to learn if the medicine is safe and how well it works for treating specific types of cancer.
- Who it's for
- The study is looking for men with castration-resistant prostate cancer who have already tried other treatments that stopped working.
- What's involved
- Participants will take mevrometostat by mouth, sometimes along with another drug called enzalutamide or a medicine called itraconazole, based on a specific schedule.
- Time commitment
- The study involves an initial assessment phase followed by a maintenance phase where you take the medicine until the cancer stops responding.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- history of CHF or evidence of ventricular dysfunction
- fructose intolerance
- coadministration of CYP3A4 substrates
The study team makes the final eligibility decision.
Where it is enrolling
- Omaha, Nebraska, United States
- Oklahoma City, Oklahoma, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Chengdu, Sichuan, China
- Krakow, Poland
- Seongnam, Kyǒnggi-do, South Korea
- Pozuelo de Alarcón, Madrid, Spain
- Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Omaha, Nebraska, United States; Oklahoma City, Oklahoma, United States; Myrtle Beach, South Carolina, United States; Nashville, Tennessee, United States; Irving, Texas, United States; San Antonio, Texas, United States and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.