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Study Summary
This trial is studying a new medicine (PF-07799544) to treat advanced solid tumors. Participants will receive the medicine and possibly other treatments. They'll be monitored by the study team during regular visits.
Who is the study for?
This trial is for people with advanced solid tumors, including brain and metastatic melanoma, where standard treatments no longer work. Participants need measurable disease by RECIST v1.1 criteria and must have progressed after the last treatment without other options. For certain substudies, a BRAF V600 mutation is required.Check my eligibility
What is being tested?
The study tests PF-07799544 as a single agent or combined with other drugs in tablet form for advanced tumor patients. Some may also take encorafenib or additional study medicines like PF-07284890 or PF-07799933 depending on their gene type and study part.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones from cancer medications include nausea, fatigue, skin reactions, increased risk of infection, liver function changes, and potential drug-specific effects which will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase)
Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase)
Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase)
+3 moreSecondary outcome measures
Duration of response overall and in CNS
Intracranial response (phase 1b Part 2)
Number of participants with clinically significant change from baseline in laboratory abnormalities
+30 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Phase 1b Substudy C Combination Dose ExpansionExperimental Treatment2 Interventions
Participants will receive PF-07799544 and PF-07799933
Group II: Phase 1b Substudy B Combination Dose ExpansionExperimental Treatment2 Interventions
Participants will receive PF-07799544 and PF-07799933
Group III: Phase 1b Substudy B Combination Dose EscalationExperimental Treatment2 Interventions
Participants will receive PF-07799544 and PF-07799933
Group IV: Monotherapy Dose Escalation (Phase 1a)Experimental Treatment2 Interventions
Participants will receive PF-07799544
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
encorafenib
2019
Completed Phase 2
~100
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Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,861 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,057 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a specific BRAF gene change.My advanced cancer, except melanoma, didn't respond to standard treatments.I have an advanced cancer that has spread, including brain cancer.I have a brain tumor larger than 4 cm.I have or had a blocked vein in my eye or a muscle disorder with high CK levels.My cancer has a BRAF V600 mutation or a similar BRAF alteration.I have been diagnosed with advanced or metastatic melanoma.My condition worsened after my last treatment and I have no other good treatment options.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Substudy B Combination Dose Expansion
- Group 2: Phase 1b Substudy C Combination Dose Expansion
- Group 3: Monotherapy Dose Escalation (Phase 1a)
- Group 4: Phase 1b Substudy B Combination Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration still available for this experiment?
"According to medical records on clinicaltrials.gov, this trial has ceased enrollment of patients after beginning the search for participants on November 11th 2022 and last updating its data on November 21st 2022. Nevertheless, there are still 4816 other studies actively recruiting individuals at present."
Answered by AI
Has the FDA sanctioned Monotherapy Dose Escalation (Phase 1a) for public use?
"Despite limited evidence of efficacy and safety, Monotherapy Dose Escalation (Phase 1a) was assigned a score of one out of three by Power's staff."
Answered by AI
Who else is applying?
What site did they apply to?
Moffitt Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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