RECRUITING

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Quick Facts

Study Start:2022-07-05
Study Completion:2028-09-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05355701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of advanced/metastatic solid tumor including primary brain tumor.
  2. * Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA).
  3. * Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).
  4. * Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies
  5. * Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.
  6. * Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor/EGFR inhibitor allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
  7. * Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor/EGFR inhibitors allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
  1. * Brain metastasis larger than 4 cm
  2. * Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
  3. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.
  4. * Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Highlands Oncology Group
Fayetteville, Arkansas, 72703
United States
Highlands Oncology Group
Rogers, Arkansas, 72758
United States
Highlands Oncology Group
Springdale, Arkansas, 72762
United States
Clinical and Translational Research Center (CTRC)
Aurora, Colorado, 80045
United States
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045
United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045
United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
United States
University of Miami Sylvester Comprehensive Cancer Center-The Griffin Research Building
Miami, Florida, 33136
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
DFCI Chestnut Hill
Newton, Massachusetts, 02459
United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
United States
CT Scan and Echo Only: Henry Ford Medical Center-Plymouth
Plymouth, Michigan, 48170
United States
MSK Monmouth
Middletown, New Jersey, 07748
United States
MSK David H. Koch Center for Cancer Care
New York, New York, 10021
United States
Memorial Sloan Kettering Cancer Center 53rd street
New York, New York, 10022
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
United States
TriStar Centennial Medical Center - Cell Processing Lab
Nashville, Tennessee, 37203
United States
TriStar Centennial Medical center
Nashville, Tennessee, 37203
United States
START San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-05
Study Completion Date2028-09-28

Study Record Updates

Study Start Date2022-07-05
Study Completion Date2028-09-28

Terms related to this study

Additional Relevant MeSH Terms

  • Melanoma
  • Non-Small-Cell Lung Cancer
  • Thyroid Cancer
  • Glioma
  • Advanced Colorectal Cancer (Part 1)