A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Melanoma
Glioma
Thyroid Cancer
Non-Small Cell Lung Cancer
Malignant Neoplasms
Brain Neoplasms
Advanced or Metastatic Solid Tumors
HGG
LGG
Low Grade Glioma
High Grade Glioma
Differentiated Thyroid Cancer
NSCLC (Non-small Cell Lung Cancer)
Спонсор: Pfizer
Налично на:
БГ
Обобщение
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).
Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:
* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)
* tumor with the mutation (abnormal gene) called "BRAF V600"
* received required prior treatment for cancer per cohort assigned.
All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.
Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Кой може да участва
Phase 1b Inclusion Criteria:
* Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
* Measurable disease by RECIST version 1.1
* Evidence of a BRAF V600 mutation
* Prior therapy per tumor cohort
* Adequate organ function per protocol
Phase 1b Exclusion Criteria:
* Other active malignancy within 3 years
* Presence of leptomeningeal disease
* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
* Active gastrointestinal disease as defined per protocol
* History of interstitial lung disease as defined per protocol
Интервенции
PF-07799544
DRUG
PF-07799933
DRUG
Места на провеждане
77
Австралия (3)
Peter MacCallum Cancer Centre
Melbourne , Victoria
The Alfred Hospital
Melbourne , Victoria
Royal Melbourne Hospital
Parkville , Victoria
Бразилия (3)
ANIMI - Unidade de Tratamento Oncologico
Lages , Santa Catarina
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul , São Paulo
IBCC - Núcleo de Pesquisa e Ensino
São Paulo
Канада (8)
Cross Cancer Institute
Edmonton , Alberta
Alberta Health Services and The Governors of The University of Alberta
Edmonton , Alberta
Jewish General Hospital
Montreal , Quebec
McGill University Health Centre
Montreal , Quebec
The Ottawa Hospital - General Campus
Ottawa , Ontario
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec , Quebec
Sunnybrook Research Institute
Toronto , Ontario
Princess Margaret Cancer Centre
Toronto , Ontario
Китай (1)
Zhejiang Cancer Hospital
Hangzhou , Zhejiang
Израел (5)
Soroka Medical Center
Beersheba , Southern District
Hadassah Medical Center
Jerusalem , Jerusalem
NOT_YET_RECRUITING
Rabin Medical Center
Petah Tikva , Central District
Sheba Medical Center
Ramat Gan , Central District
Sourasky Medical Center
Tel Aviv , TELL ABĪB
Япония (2)
Kansai Medical University Hospital
Hirakata , Osaka
NOT_YET_RECRUITING
National Cancer Center Hospital East
Kashiwa , Chiba
NOT_YET_RECRUITING
САЩ (55)
MSK Basking Ridge.
Basking Ridge , New Jersey
The Kirklin Clinic of UAB Hospital
Birmingham , Alabama
The University of Alabama at Birmingham
Birmingham , Alabama
University of Alabama at Birmingham - Phase I Clinical Trials Unit
Birmingham , Alabama
Brigham and Women's Hospital
Boston , Massachusetts
Dana Farber Cancer Institute
Boston , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
Optum Medical Care, PC
Brewster , New York
NOT_YET_RECRUITING
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland , Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland , Ohio
MSK Commack.
Commack , New York
Brigitte Harris Cancer Pavilion
Detroit , Michigan
Henry Ford Hospital
Detroit , Michigan
Highlands Oncology Group, PA
Fayetteville , Arkansas
MSK Westchester.
Harrison , New York
University of Texas MD Anderson Cancer Center
Houston , Texas
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
Los Angeles , California
Keck Hospital of USC
Los Angeles , California
NOT_YET_RECRUITING
Los Angeles General Medical Center
Los Angeles , California
NOT_YET_RECRUITING
USC/Norris Comprehensive Cancer Center
Los Angeles , California
NOT_YET_RECRUITING
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison , Wisconsin
University of Wisconsin Carbone Cancer Center - University Hospital
Madison , Wisconsin
MSK Monmouth.
Middletown , New Jersey
MSK Bergen.
Montvale , New Jersey
Optum Medical Care, PC
Mount Kisco , New York
NOT_YET_RECRUITING
SCRI Oncology Partners
Nashville , Tennessee
Ochsner Clinic Foundation
New Orleans , Louisiana
NOT_YET_RECRUITING
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York , New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York , New York
NYU Langone Faculty Group Practice
New York , New York
NYU Langone Medical Center (Tisch Hospital)
New York , New York
Memorial Sloan Kettering Cancer Center 53rd street.
New York , New York
Columbia University Irving Medical Center
New York , New York
Columbia University Medical Center - Neurological Institute of New York
New York , New York
CUIMC Research Pharmacy
New York , New York
Memorial Sloan Kettering Cancer Center - Main Campus
New York , New York
Keck Medical Center of USC Pasadena
Pasadena , California
NOT_YET_RECRUITING
UPMC Hillman Cancer Center
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Providence Cancer Institute Franz Clinic
Portland , Oregon
Providence Portland Medical Center
Portland , Oregon
Highlands Oncology Group, PA
Rogers , Arkansas
HealthPartners Frauenshuh Cancer Center
Saint Louis Park , Minnesota
NOT_YET_RECRUITING
Methodist Hospital Inpatient Pharmacy
Saint Louis Park , Minnesota
NOT_YET_RECRUITING
HealthPartners Cancer Center at regions Hospital
Saint Paul , Minnesota
NOT_YET_RECRUITING
Regions Hospital Pharmacy
Saint Paul , Minnesota
NOT_YET_RECRUITING
UCSF Medical Center, Investigational Pharmacy
San Francisco , California
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco , California
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica , California
Fred Hutchinson Cancer Center
Seattle , Washington
University of Washington Medical Center
Seattle , Washington
Highlands Oncology Group, PA
Springdale , Arkansas
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
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