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Small Molecule Inhibitor

PF-07284890 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks from time of enrollment up to 1 year, then every 12 weeks thereafter
Awards & highlights

Study Summary

This trial is testing a new drug, PF-07284890, for safety and how well it works in people with BRAF V600-mutated solid tumors.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Cancer
  • Melanoma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks from time of enrollment up to 1 year, then every 12 weeks thereafter
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks from time of enrollment up to 1 year, then every 12 weeks thereafter for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1a - Number of dose interruptions, dose modifications, and discontinuations due to AEs
Phase 1a - Number of participants with clinically significant change from baseline in laboratory abnormalities
Phase 1a - Number of participants with dose limiting toxicities (DLTs)
+2 more
Secondary outcome measures
Phase 1a: Accumulation ratio (Rac) of PF-07284890 and binimetinib
Phase 1a: Apparent oral clearance (CL/F) of CYP3A4 probe substrate midazolam
Phase 1a: Apparent oral clearance of PF-07284890 and binimetinib
+33 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: PF-07284890+binimetinib (Part A combo-therapy)Experimental Treatment2 Interventions
Combination dose escalation of PF-07284890 + binimetinib
Group II: PF-07284890 (Part A monotherapy)Experimental Treatment1 Intervention
Monotherapy dose escalation of PF-07284890
Group III: Expansion Phase Drug-Drug Interaction Substudy (Part B Optional Cohort 6)Experimental Treatment3 Interventions
PF-07284890 (at recommended dose from Part A) plus binimetinib plus midazolam in participants with BRAF V600 solid tumor
Group IV: Expansion Phase (Part B, Cohort 4)Experimental Treatment2 Interventions
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with symptomatic brain involvement, and prior BRAF inhibitor utilization
Group V: Expansion Phase (Part B, Cohort 3)Experimental Treatment2 Interventions
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with asymptomatic brain involvement, and prior BRAF inhibitor utilization
Group VI: Expansion Phase (Part B, Cohort 2)Experimental Treatment2 Interventions
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with symptomatic brain involvement, and no prior BRAF or MEK inhibitor utilization
Group VII: Expansion Phase (Part B, Cohort 1)Experimental Treatment2 Interventions
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with asymptomatic brain involvement, and no prior BRAF or MEK inhibitor utilization
Group VIII: Expansion Phase (Part B Optional Cohort 7)Experimental Treatment2 Interventions
PF-07284890 (at the recommended dose for expansion when administered with food) plus binimetinib in participants with BRAF V600 solid tumor
Group IX: Expansion Phase (Part B Cohort 5)Experimental Treatment2 Interventions
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 solid tumor; history of or current leptomeningeal metastases; without disease in the brain; with disease in the brain that does not meet Cohorts 1-4; asymptomatic or symptomatic in the brain; primary brain tumors
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Midazolam
FDA approved

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,375 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,489 Total Patients Enrolled

Media Library

Binimetinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04543188 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Expansion Phase (Part B Cohort 5), Expansion Phase (Part B, Cohort 1), Expansion Phase (Part B, Cohort 2), Expansion Phase (Part B Optional Cohort 7), Expansion Phase (Part B, Cohort 3), Expansion Phase Drug-Drug Interaction Substudy (Part B Optional Cohort 6), PF-07284890 (Part A monotherapy), Expansion Phase (Part B, Cohort 4), PF-07284890+binimetinib (Part A combo-therapy)
Non-Small Cell Lung Cancer Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04543188 — Phase 1
Binimetinib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04543188 — Phase 1

Frequently Asked Questions

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

Are there any other scientific investigations into the effects of PF-07284890?

"In 2009, PF-07284890 was first tested at Shaare Zedek Medical Center. Subsequently, there have been 576 completed trials and 122 ongoing studies of this medication across the United States with a concentration in Boston, Massachusetts."

Answered by AI

In what geographical areas is the experiment being conducted?

"As of now, 64 study participants have enrolled in this trial from various locations including Brigham & Women's Hospital in Boston, The University of Kansas Hospital in Kansas City, and Orlando Health Cancer Institute."

Answered by AI

What is the size of this experiment's cohort?

"To complete this clinical trial, 138 participants that meet the specified criteria are required. These patients can join from Brigham & Women's Hospital in Boston or The University of Kansas Hospital in Kansas City."

Answered by AI

What medical indications is PF-07284890 typically prescribed for?

"PF-07284890 has been prescribed to treat braf v600e mutation, as well as central nervous system depressants, preoperative sedation, and anaesthesia therapy."

Answered by AI

What objectives have been established for this trial's success?

"This medical experiment's primary objective is to monitor how many participants experience a tangible shift in laboratory values from their baseline. Secondary objectives include tracking the maximum plasma concentration of PF-07284890 and binimetinib as well as calculating AUClast, AUCinf single dose PK parameters for these compounds."

Answered by AI

Has the FDA granted authorization to utilize PF-07284890?

"Due to the fact that PF-07284890 is currently in its first phase of testing, our team at Power assign it a level 1 safety rating. That being said, there are only limited amounts of data proving efficacy and safety."

Answered by AI

Is enrollment in this research endeavor currently available to participants?

"Per information found on clinicaltrials.gov, this research is actively searching for participants; it was first advertised on the 8th of January 2021 and had its most recent update registered on 16th November 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
2021. "A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04543188.
~15 spots leftby Apr 2025
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