No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
453 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for men with Castration Resistant Prostate Cancer who have already received treatment but their cancer has progressed. Participants will receive the study medicine Mevrometostat and may take other medications as part of the trial.
Are You a Good Fit for This Trial?
Rules you outHistory of CHFVentricular dysfunctionFructose intolerance
You may be able to join if
I have been diagnosed with castration resistant prostate cancer.
I have a performance status of 0-2 and can expect to live at least 6 months.
I have good bone marrow, kidney, and liver function.
You may not be able to join if
I have had radiation treatment to more than 25% of my bone marrow.
I have a QTcF interval longer than 480 msec.
I have uncontrolled high blood pressure.
I am allergic to Mevrometostat or enzalutamide.
I have an active gastrointestinal disease or chronic diarrhea.
I am currently taking strong or moderate CYP3A4 inducers or inhibitors.
I have taken enzalutamide in the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Par…
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.
Trial Locations
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City
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Status
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 …
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
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