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Набира участници Фаза 1 NCT05355701

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Melanoma Non-Small-Cell Lung Cancer Thyroid Cancer Glioma Advanced Colorectal Cancer (Part 1)

Спонсор: Pfizer

Налично на: БГ
Обобщение
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.
Кой може да участва
This study is seeking participants who meet the following key eligibility criteria: Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor including primary brain tumor. * 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). * 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)). * Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies * 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. * 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. * 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. Exclusion Criteria: * Brain metastasis larger than 4 cm * Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease. * Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).
Интервенции
PF-07799933
DRUG
binimetinib
DRUG
cetuximab
BIOLOGICAL
midazolam
DRUG
fluorouracil
DRUG
leucovorin
DRUG
oxaliplatin
DRUG
Места на провеждане 41
Канада (5)
Jewish General Hospital
Montreal , Quebec
McGill University Health Centre
Montreal , Quebec
The Ottawa Hospital - General Campus
Ottawa , Ontario
University Health Network
Toronto , Ontario
Princess Margaret Cancer Centre
Toronto , Ontario
Израел (5)
Rambam Health Care Campus
Haifa , Ḥeifā
Hadassah Medical Center
Jerusalem , Jerusalem
Sheba Medical Center
Ramat Gan , Central District
Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv , Central District
САЩ (31)
Clinical and Translational Research Center (CTRC)
Aurora , Colorado
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora , Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora , Colorado
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora , Colorado
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora , Colorado
Brigham and Women's Hospital
Boston , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland , Ohio
Cleveland Clinic
Cleveland , Ohio
Brigitte Harris Cancer Pavilion
Detroit , Michigan
Henry Ford Hospital
Detroit , Michigan
Highlands Oncology Group
Fayetteville , Arkansas
Sylvester Comprehensive Cancer Center
Miami , Florida
University of Miami Hospital and Clinics
Miami , Florida
MSK Monmouth
Middletown , New Jersey
Sarah Cannon Research Institute - Pharmacy
Nashville , Tennessee
SCRI Oncology Partners
Nashville , Tennessee
TriStar Bone Marrow Transplant
Nashville , Tennessee
TriStar Centennial Medical Center - Cell Processing Lab
Nashville , Tennessee
TriStar Centennial Medical center
Nashville , Tennessee
MSK David H. Koch Center for Cancer Care
New York , New York
Memorial Sloan Kettering Cancer Center 53rd street
New York , New York
Memorial Sloan Kettering Cancer Center
New York , New York
DFCI Chestnut Hill
Newton , Massachusetts
Henry Ford Medical Center - Columbus
Novi , Michigan
CT Scan and Echo Only: Henry Ford Medical Center-Plymouth
Plymouth , Michigan
Providence Cancer Institute Franz Clinic
Portland , Oregon
Providence Portland Medical Center
Portland , Oregon
Highlands Oncology Group
Rogers , Arkansas
START San Antonio
San Antonio , Texas
Highlands Oncology Group
Springdale , Arkansas
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Здрави доброволци
Не
Начална дата
05.07.2022
Крайна дата
06.08.2030
Регистрационен номер
NCT05355701
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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