What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including androgen receptor-directed therapies like enzalutamide, chemotherapy agents like docetaxel, and radionuclide treatments like lutetium Lu 177 vipivotide tetraxetan, have a range of side effects. Enzalutamide can cause fatigue, anorexia, and nausea. Docetaxel is associated with myelosuppression, neuropathy, and gastrointestinal symptoms. Radionuclide treatments often result in myelosuppression, nephrotoxicity, and salivary gland toxicity. These side effects are important considerations when evaluating novel therapeutic agents like PF-06821497, which may have similar adverse effects due to targeting specific molecular pathways in cancer.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for prostate cancer, focusing on specific molecular pathways. Androgen receptor signaling inhibitors such as enzalutamide, apalutamide, and darolutamide block the androgen receptor pathway, crucial in prostate cancer progression. Abiraterone acetate, another approved drug, inhibits CYP17, an enzyme involved in androgen production. Radioligand therapy with lutetium Lu 177 vipivotide tetraxetan targets PSMA-positive metastatic castration-resistant prostate cancer (CRPC). These treatments represent significant advancements in targeting molecular pathways in prostate cancer.

What other types of research exist?

Promising novel alternatives to PF-06821497 for prostate cancer patients include: 1) Sorafenib, 2) Olaparib, 3) Elesclomol, 4) Tanespimycin, 5) Ponatinib, and 6) Lenalidomide in combination with Pazopanib. These drugs have been identified as potentially active for the treatment of castration-resistant prostate cancer (CRPC) through computational and clinical research.

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BCL-2 Inhibitor

PF-06821497 for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Pfizer

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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 2 years for reporting.

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 more

Secondary 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 more

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

~2970

0 / 6Eligibility criteria met

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.