PF-07799933 for Melanoma
Phase-Based Progress Estimates
Effectiveness
Safety
Highlands Oncology Group, Fayetteville, AR
Melanoma+5 More
PF-07799933 - DrugEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines (called binimetinib and cetuximab) in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 1 or 2 times a day. Depending on the part of the study, participants may also receive another study medicine: People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. People with colorectal cancer may also receive cetuximab. Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Eligible Conditions
- Melanoma
- Colorectal Carcinoma
- Non-Small Cell Lung Carcinoma (NSCLC)
- Glioma
- Thyroid Cancers
Treatment Effectiveness
Effectiveness Progress
Study Objectives
11 Primary · 42 Secondary · Reporting Duration: Baseline to 2 years
Baseline to 2 years
Discontinuations due to AEs (Part 1 and Part 2)
Dose dose modifications due to AEs (Part 1 and Part 2)
Dose interruptions due to AEs (Part 1 and Part 2)
Overall response rate (ORR) (Part 3)
Part 1 and Part 2: Duration of response
Part 1 and Part 2: ORR
Part 1/2/3: Intracranial response
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, CL/F
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, Vz/F
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, accumulation ratio (Rac)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, average plasma concentration (Cav)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, peak-to-trough ratio (PTR)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, t1/2
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, trough plasma or serum concentration (Ctrough)
Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F)
Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F)
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 24 hours (AUC24)
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 48 hours (AUC48)
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
Part 1/2/3: PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax)
Part 1/2/3: PK parameters of PF-07799933, Single dose, terminal elimination half life (t½)
Part 1/2/3: PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax)
Part 3: DOR
Part 3: Discontinuations due to AEs
Part 3: Disease Control Rate (DCR)
Part 3: Dose dose modifications due to AEs
Part 3: Dose interruptions due to AEs
Part 3: Number of participants with clinically significant change from baseline in laboratory abnormalities
Part 3: Number of participants with clinically significant change from baseline in vital sign abnormalities
Part 3: Number of participants with treatment-emergent adverse events (AEs)
Part 3: OS
Part 3: PFS
Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUCinf
Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUClast
Part 3: PK parameters of CYP3A4 probe substrate midazolam, CL/F
Part 3: PK parameters of CYP3A4 probe substrate midazolam, Tmax
Part 3: PK parameters of CYP3A4 probe substrate midazolam, Vz/F
Part 3: PK parameters of CYP3A4 probe substrate midazolam, t½
Part 3: PK parameters of cytochrome P450 (CYP)3A4 probe substrate midazolam, Cmax
Part 3: TTR
Part 3: Time to event endpoints in each combination
Day 28
Number of participants with clinically significant physical exam abnormalities (Part 3)
Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2)
Day 28
Number of participants with clinically significant change from baseline in laboratory abnormalities (Part 1 and Part 2)
Number of participants with clinically significant change from baseline in vital sign abnormalities (Part 1 and Part 2)
Number of participants with clinically significant physical exam abnormalities (Part 1 and Part 2)
Cycle 1 (21 days)
MTD (Part 1 and Part 2)
Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)
RDE (Part 1 and Part 2)
Trial Safety
Safety Progress
Trial Design
8 Treatment Groups
Monotherapy dose escalation (Part 1)
1 of 8
Dose expansion (Part 3) - Basket Cohort 6
1 of 8
Dose expansion (Part 3) - Tumor and mutation specific Cohort 5
1 of 8
Combination dose escalation (Part 2)
1 of 8
Dose expansion (Part 3) - Tumor and mutation specific Cohort 3
1 of 8
Dose expansion (Part 3) - Tumor and mutation specific Cohort 4
1 of 8
Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
1 of 8
Dose expansion (Part 3) - Tumor and mutation specific Cohort 2
1 of 8
Experimental Treatment
174 Total Participants · 8 Treatment Groups
Primary Treatment: PF-07799933 · No Placebo Group · Phase 1
Monotherapy dose escalation (Part 1)
Drug
Experimental Group · 1 Intervention: PF-07799933 · Intervention Types: DrugDose expansion (Part 3) - Basket Cohort 6Experimental Group · 3 Interventions: cetuximab, PF-07799933, binimetinib · Intervention Types: Biological, Drug, Drug
Dose expansion (Part 3) - Tumor and mutation specific Cohort 5Experimental Group · 2 Interventions: cetuximab, PF-07799933 · Intervention Types: Biological, Drug
Combination dose escalation (Part 2)Experimental Group · 3 Interventions: cetuximab, PF-07799933, binimetinib · Intervention Types: Biological, Drug, Drug
Dose expansion (Part 3) - Tumor and mutation specific Cohort 3
Drug
Experimental Group · 1 Intervention: PF-07799933 · Intervention Types: DrugDose expansion (Part 3) - Tumor and mutation specific Cohort 4Experimental Group · 2 Interventions: cetuximab, PF-07799933 · Intervention Types: Biological, Drug
Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
Drug
Experimental Group · 1 Intervention: PF-07799933 · Intervention Types: DrugDose expansion (Part 3) - Tumor and mutation specific Cohort 2Experimental Group · 2 Interventions: PF-07799933, binimetinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cetuximab
2000
Completed Phase 3
~7290
binimetinib
2017
Completed Phase 2
~80
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 2 years
Closest Location: Highlands Oncology Group · Fayetteville, AR
2001First Recorded Clinical Trial
12 TrialsResearching Melanoma
112 CompletedClinical Trials
Who is running the clinical trial?
PfizerLead Sponsor
4,229 Previous Clinical Trials
6,666,407 Total Patients Enrolled
46 Trials studying Melanoma
49,523 Patients Enrolled for Melanoma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,226 Previous Clinical Trials
4,383,256 Total Patients Enrolled
22 Trials studying Melanoma
3,641 Patients Enrolled for Melanoma
Eligibility Criteria
Age Any Age · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a diagnosis of advanced/metastatic solid tumor including primary brain tumor.
You have had a disease for at least 18 months and have not responded to other treatments.
You have a tumor that has received specific prior approved therapies.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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