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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Dose Escalation (Part 1A)
- Group 2: Dose Escalation (Part 1B)
- Group 3: Dose Escalation (Part 1C)
- Group 4: Dose Escalation (Part 2A)
- Group 5: Dose Expansion (Part 2B)
- Group 6: Japan Cohort
- Group 7: China cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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