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NCT05355701 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 267
- Enrollment target
- 20
- Study locations
NCT05355701: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Pfizer.
NCT05355701 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is actively recruiting participants, run by Pfizer. The registered enrollment target is 267 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05355701, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 267 participants
- Enrollment target
- 20
- Study locations
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 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, 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 or cetuximab and mFOLFOX6 (Chemotherapy regimen). 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.
Primary Outcome
DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab
Conditions Studied
Interventions
- DRUG PF-07799933
- DRUG binimetinib
- DRUG fluorouracil
- BIOLOGICAL cetuximab
- DRUG midazolam
Study Locations (20)
Colorado
- Clinical and Translational Research Center (CTRC) - Aurora
- UCHealth Sue Anschutz-Rodgers Eye Center - Aurora
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) - Aurora
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) - Aurora
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) - Aurora
Michigan
- Brigitte Harris Cancer Pavilion - Detroit
- Henry Ford Hospital - Detroit
- Henry Ford Medical Center - Columbus - Novi
- CT Scan and Echo Only: Henry Ford Medical Center-Plymouth - Plymouth
Arkansas
- Highlands Oncology Group - Fayetteville
- Highlands Oncology Group - Rogers
- Highlands Oncology Group - Springdale
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- DFCI Chestnut Hill - Newton
Florida
- University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami
- University of Miami Sylvester Comprehensive Cancer Center-The Griffin Research Building - Miami
New York
- MSK David H. Koch Center for Cancer Care - New York
- Memorial Sloan Kettering Cancer Center 53rd street - New York
New Jersey
- MSK Monmouth - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2030-05-06 |
| Phase | Phase 1 |
What NCT05355701 shows while recruiting
NCT05355701 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (59% lower).
The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which PF-07799933 is the first listed.
NCT05355701 names 20 study sites across 7 states, led by Colorado, Michigan, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05355701 about?
NCT05355701 is a clinical study titled "A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.". 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 in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a...
What is the current status of trial NCT05355701?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 267 participants. The study started on 2022-07-05. Estimated completion is 2030-05-06.
What conditions does trial NCT05355701 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Glioma, Thyroid Cancer, Advanced Colorectal Cancer (Part 1).
What interventions are being tested in trial NCT05355701?
The interventions under investigation include: PF-07799933 (DRUG), binimetinib (DRUG), fluorouracil (DRUG), cetuximab (BIOLOGICAL), midazolam (DRUG).
Who is sponsoring clinical trial NCT05355701?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05355701 being conducted?
This trial has 20 study locations across Arkansas, Colorado, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05355701's enrollment target sits among peer trials
267 142nd of 454 higher than 313 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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