Trial Title:
A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors
NCT ID:
NCT05538130
Condition:
Melanoma
Glioma
Thyroid Cancer
Non-Small Cell Lung Cancer
Malignant Neoplasms
Brain Neoplasms
Colorectal Cancer
Conditions: Official terms:
Neoplasms
Melanoma
Brain Neoplasms
Conditions: Keywords:
Proto-Oncogene Proteins B-raf
Brain neoplasms
Melanoma
Carcinoma, Non-Small-Cell Lung
Neoplasm by Histologic Type
CRC
MAPK
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PF-07799544
Description:
Tablet
Arm group label:
Monotherapy Dose Escalation (Phase 1a)
Arm group label:
Phase 1b Substudy B Combination Dose Escalation
Arm group label:
Phase 1b Substudy B Combination Dose Expansion
Arm group label:
Phase 1b Substudy C Combination Dose Expansion
Other name:
ARRY-134
Intervention type:
Drug
Intervention name:
PF-07799933
Description:
Tablet
Arm group label:
Phase 1b Substudy B Combination Dose Escalation
Arm group label:
Phase 1b Substudy B Combination Dose Expansion
Arm group label:
Phase 1b Substudy C Combination Dose Expansion
Other name:
ARRY-440
Intervention type:
Drug
Intervention name:
encorafenib
Description:
Capsule
Arm group label:
Monotherapy Dose Escalation (Phase 1a)
Other name:
BRAFTOVI
Summary:
The purpose of this clinical trial is to learn the safety and effects of the study
medicine (PF-07799544) administered as a single agent and in combination with other study
medications in people with solid tumors. This study is seeking participants who have an
advanced solid tumor for which the available treatments are no longer effective in
controlling their cancer. All participants in this study will receive PF-07799544.
PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this
could change to once daily or another frequency). Depending on the part of the study,
participants may also receive another study medicine.
- In the first part of the study, people with melanoma or other solid tumors may also
receive encorafenib. Encorafenib comes as a capsule and is taken once per day.
- In the second part of the study, people with melanoma or other cancers with
abnormalities in a gene called "BRAF" will receive PF-07799544 with other study
medicines (for example, PF-07799933).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of advanced/metastatic solid tumor including primary brain tumor for
monotherapy phase 1a dose escalation
- Disease progressed during/following last prior treatment and no satisfactory
alternative treatment options for monotherapy phase 1a dose escalation
- For Substudy B, histological or cytological diagnosis of advanced/metastatic
melanoma
- For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with
demonstrated intolerance to SOC, excluding melanoma,
- For Substudy B and C, measurable disease by RECIST version 1.1
- For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in
tumor tissue and/or blood
- For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF
alteration)
Exclusion Criteria:
- Brain metastasis larger than 4 cm
- History or current evidence of retinal vein occlusion (RVO) or concurrent
neuromuscular disorder associated with elevated creatine kinase (CK)
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group, PA
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group, PA
Address:
City:
Rogers
Zip:
72758
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group
Address:
City:
Rogers
Zip:
72758
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group, PA
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
Highlands Oncology
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt McKinley Hospital
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Eye Center at Florida Medical Clinic
Address:
City:
Tampa
Zip:
33613
Country:
United States
Status:
Recruiting
Facility:
Name:
Brigitte Harris Cancer Pavilion
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
CUIMC Research Pharmacy
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Taussig Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Cancer Institute Franz Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Washington Medical Center
Address:
City:
Seattle
Zip:
98195
Country:
United States
Status:
Recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Sunnybrook Research Institute
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Address:
City:
Quebec City
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Start date:
November 30, 2022
Completion date:
September 28, 2028
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538130
https://pmiform.com/clinical-trial-info-request?StudyID=C4901001
