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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 2 years

Awards & highlights

Study Summary

This trial is testing a new drug to treat adult patients with small cell lung cancer, castration resistant prostate cancer, or follicular lymphoma who have relapsed or are refractory to standard therapies.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall safety profile including adverse events

Overall safety profile including laboratory abnormalities

Overall safety profile including vital signs

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Secondary outcome measures

Evaluate overall survival

Evaluate the impact of PF-06821497 on patient reported outcomes.

Evaluate time to event anti-tumor activity of PF-06821497 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.

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Trial Design

7Treatment groups

Experimental Treatment

Group I: Japan CohortExperimental Treatment1 Intervention

Participants with CRPC will receive PF-06821497 at one or two doses

Group II: Dose Expansion (Part 2B)Experimental Treatment1 Intervention

Participants with CRPC will receive PF-06821497 in combination with SOC or SOC alone.

Group III: Dose Escalation (Part 2A)Experimental Treatment1 Intervention

Participants with CRPC and SCLC will receive PF-06821497 at escalating dose levels in combination with SOC.

Group IV: Dose Escalation (Part 1C)Experimental Treatment1 Intervention

Participants with CRPC will receive PF-06821497 at escalating dose levels.

Group V: Dose Escalation (Part 1B)Experimental Treatment1 Intervention

Participants with FL will receive PF-06821497 at escalating dose levels

Group VI: Dose Escalation (Part 1A)Experimental Treatment1 Intervention

Participants with SCLC, CRPC and FL will receive PF-06821497 at escalating dose levels

Group VII: China cohortExperimental Treatment1 Intervention

Participants will receive PF-06821497 at one or two doses

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,719 Total Patients Enrolled

42 Trials studying Prostate Cancer

12,370 Patients Enrolled for Prostate Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,914 Total Patients Enrolled

8 Trials studying Prostate Cancer

3,418 Patients Enrolled for Prostate Cancer

Media Library

PF-06821497 (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03460977 — Phase 1

Prostate Cancer Research Study Groups: Dose Escalation (Part 1A), Dose Escalation (Part 1B), Dose Escalation (Part 1C), Dose Escalation (Part 2A), Dose Expansion (Part 2B), Japan Cohort, China cohort

Prostate Cancer Clinical Trial 2023: PF-06821497 Highlights & Side Effects. Trial Name: NCT03460977 — Phase 1

PF-06821497 (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03460977 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate number of people involved in this clinical experiment?

"This clinical trial requires 185 eligible participants. Interested parties can find a host of participating medical centres, such as Washington University Infusion Center Pharmacy in Saint Louis and Siteman Cancer Center - St. Peters in Saint Peters, California."

Answered by AI

Is this a groundbreaking clinical trial?

"Research on PF-06821497 began in 2018, with a study sponsored by Pfizer. After the initial 185 subject trial concluded, it passed Phase 1 drug approval and presently there is one active instance of research underwritten by Pfizer."

Answered by AI

Can you share any previous experiments with PF-06821497?

"At present, 1 clinical trial is investigating PF-06821497. None of these active tests are in the third phase yet. While Irving, Texas serves as the main hub for research into this treatment, 75 different facilities across the country have initiated studies involving PF-06821497."

Answered by AI

Is there an opportunity to join this scientific research endeavor?

"According to the official clinicaltrials.gov website, this medical trial is accepting patients as of November 21st 2022. The study was initially posted on April 17th 2018."

Answered by AI

Has the FDA sanctioned PF-06821497 as an accepted treatment?

"Limted data exists to assess the safety and efficacy of PF-06821497, thus it was assigned a value of 1 on our risk assessment scale."

Answered by AI

What purpose does this medical experiment seek to attain?

"According to the primary sponsor, Pfizer, the main outcome measure of this study will be Percentage of patients with dose limiting toxicities (DLTs). Additionally, secondary objectives such as Progression-free Survival (PFS) and Metastatic Free Survival (MFS), Maximum Observed Plasma Concentration (Cmax) and Apparent Oral Clearance (CL/F) will also be evaluated. The trial is expected to conclude in two years following patient recruitment."

Answered by AI

How many different sites are hosting this research endeavor?

"The current list of participating medical centres for this trial consists of 33 sites, such as Washington University Infusion Centre Pharmacy in St. Louis, Siteman Cancer Center - St. Peters in Saint Peter's and Pacific Cancer Medical Centre INC in Anaheim."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

2018. "PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03460977.

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