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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks from time of enrollment up to 1 year, then every 12 weeks thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks from time of enrollment up to 1 year, then every 12 weeks thereafter
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 moreSecondary 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 moreTrial 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
4,580 Previous Clinical Trials
14,634,137 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,811,012 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Expansion Phase (Part B Cohort 5)
- Group 2: Expansion Phase (Part B, Cohort 1)
- Group 3: Expansion Phase (Part B, Cohort 2)
- Group 4: Expansion Phase (Part B Optional Cohort 7)
- Group 5: Expansion Phase (Part B, Cohort 3)
- Group 6: Expansion Phase Drug-Drug Interaction Substudy (Part B Optional Cohort 6)
- Group 7: PF-07284890 (Part A monotherapy)
- Group 8: Expansion Phase (Part B, Cohort 4)
- Group 9: PF-07284890+binimetinib (Part A combo-therapy)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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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