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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological diagnosis of advanced/metastatic solid tumor with specified tumor types in individual study parts
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Must not have
Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery
Current use or anticipated need for specific food or drugs known to interact with investigational product
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called PF-06821497 to see if it can help adults with certain hard-to-treat cancers. The drug is taken by mouth and is being studied alone or with other treatments to check its safety and effectiveness in stopping cancer growth.
Who is the study for?
This trial is for adults with advanced lung cancer, prostate cancer resistant to hormone therapy, or follicular lymphoma. Participants must have a confirmed diagnosis, adequate organ function, and an ECOG Performance Status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory). They should not be using certain foods/drugs that affect the study medication.
What is being tested?
PF-06821497 is being tested in this Phase 1 trial to find out the best dose and its safety for treating relapsed/refractory small cell lung cancer (SCLC), castration-resistant prostate cancer (CRPC), and follicular lymphoma (FL). The study will gradually increase doses for new patients based on how earlier participants respond.
What are the potential side effects?
Potential side effects of PF-06821497 are not specified here but may include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes leading to increased infection risk, liver function alterations, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread, and it's one of the specified types in the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious stomach or bowel problems.
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I am not using, nor do I need, any substances that could affect the trial medication.
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More than a quarter of my bone marrow has been exposed to radiation.
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My high blood pressure is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate time to event mevrometostat and enzalutamide vs enzalutamide alone including radiographic prgression free survival
Overall safety profile including adverse events
Overall safety profile including laboratory abnormalities
+3 moreSecondary study objectives
Evaluate overall survival
Evaluate the impact of mevrometostat on patient reported outcomes.
Evaluate time to event anti-tumor activity of mevrometostat including progression-free survival (PFS), PSA50, Duration of Response (DoR), Time to first skeletal related event and Time to symptomatic skeletal related event, depending on tumor type.
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Japan CohortExperimental Treatment1 Intervention
Participants with CRPC will receive mevrometostat at one or two doses
Group II: Dose Expansion (Part 2C)Experimental Treatment2 Interventions
Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC
Group III: Dose Expansion (Part 2B)Experimental Treatment2 Interventions
Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
Group IV: Dose Escalation (Part 2A)Experimental Treatment2 Interventions
Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
Group V: Dose Escalation (Part 1C)Experimental Treatment1 Intervention
Participants with mCRPC will receive PF-06821497 at escalating dose levels.
Group VI: Dose Escalation (Part 1B)Experimental Treatment1 Intervention
Participants with FL will receive mevrometostat at escalating dose levels
Group VII: Dose Escalation (Part 1A)Experimental Treatment1 Intervention
Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
Group VIII: China cohortExperimental Treatment1 Intervention
Participants will receive mevrometostat at one or two doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~3820
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to prevent cancer growth, and androgen receptor inhibitors like enzalutamide and abiraterone, which block androgen signaling. Additionally, poly(ADP-ribose) polymerase (PARP) inhibitors target DNA repair mechanisms in cancer cells with homologous recombination repair (HRR) deficiencies.
Understanding these mechanisms is crucial for patients as it helps tailor treatments based on the molecular characteristics of their cancer, potentially improving efficacy and reducing side effects. Novel agents like PF-06821497, which may target specific molecular pathways, represent a promising area of research, offering hope for more effective and personalized therapies.
Targeting molecular resistance in castration-resistant prostate cancer.
Targeting molecular resistance in castration-resistant prostate cancer.
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Who is running the clinical trial?
PfizerLead Sponsor
4,658 Previous Clinical Trials
17,876,940 Total Patients Enrolled
43 Trials studying Prostate Cancer
12,839 Patients Enrolled for Prostate Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,116 Total Patients Enrolled
9 Trials studying Prostate Cancer
3,918 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's QTcF interval is longer than 480 milliseconds when measured during screening.I have a history of serious stomach or bowel problems.I am not using, nor do I need, any substances that could affect the trial medication.My cancer is advanced or has spread, and it's one of the specified types in the study.My prostate cancer is resistant to hormonal therapy.Patients with signs of disease on imaging tests.My organs are working well.I have specific limits on past chemotherapy based on the study's phase.More than a quarter of my bone marrow has been exposed to radiation.My high blood pressure is not under control.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion (Part 2C)
- Group 2: Dose Escalation (Part 1A)
- Group 3: Dose Escalation (Part 1B)
- Group 4: Dose Escalation (Part 1C)
- Group 5: Dose Escalation (Part 2A)
- Group 6: Dose Expansion (Part 2B)
- Group 7: Japan Cohort
- Group 8: China cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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