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New treatment option 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 Mervometostat (PF-06821497)?
Mervometostat (PF-06821497) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic castration resistant prostate cancer (mcrpc).
Also referred to as EZH2i.
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
- 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.
- 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
- DDI SUBSTUDY:
- history of CHF or evidence of ventricular dysfunction
- fructose intolerance
- coadministration of CYP3A4 substrates
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Anaheim, California, United States
- Duarte, California, United States
- Norwalk, Connecticut, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Newton, Massachusetts, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
- Oklahoma City, Oklahoma, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Irving, Texas, United States
+ 30 more site(s).
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 - 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?
Study sites include Tucson, Arizona, United States; Anaheim, California, United States; Duarte, California, United States; Norwalk, Connecticut, United States; Fairway, Kansas, United States; Kansas City, Kansas, United States and 44 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.