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RecruitingPhase 1

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of mevrometostat, a study drug for cancer. The open part is for men whose prostate cancer keeps growing despite treatment to lower testosterone and has worsened after their last treatment. Participants will take mevrometostat and/or enzalutamide; the other parts of the study are closed.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer confirmed by a tissue or cell test that keeps growing despite treatment to lower testosterone.
  • Have had treatment for this cancer, with the cancer getting worse after the last treatment.
  • Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
  • Be expected to live at least 6 months.
  • Have bone marrow, kidneys, and liver that work well enough. Bone marrow makes blood cells.

Who can't join

  • Have had radiation to more than 25% of your bone marrow.
  • Have a heart test showing a QTcF over 480 milliseconds, meaning the heart takes too long to reset between beats.
  • Have blood pressure above 150/90 despite the best treatment with medicines.
  • Have a known or suspected allergy to mevrometostat (PF 06821497), its ingredients, or enzalutamide.
  • Have active swelling in the stomach or intestines, long-term diarrhea, or pouches in the bowel wall; or have had part of the stomach removed or lap band surgery.
  • Use or expect to need foods or drugs that strongly or moderately change how certain liver proteins, called CYP3A4/5, break down medicines.
  • Have taken enzalutamide in the past 4 weeks.
  • For the drug-interaction substudy only: have a history of heart failure or signs of weak heart pumping, cannot digest fructose (a type of sugar), or take drugs broken down by the liver protein CYP3A4.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (45)

AZ

CA

CT

KS

KY

MA

MD

NE

NJ

OK

SC

TN

TX

VA

WA