Actively Recruiting
A Study of Sotorasib in People With Brain Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-05-22
16
Participants Needed
7
Research Sites
152 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.
CONDITIONS
Official Title
A Study of Sotorasib in People With Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older with one or more brain tumors planned for neurosurgical resection or biopsy
- Patients with leptomeningeal metastasis are eligible if they have brain tumors requiring surgery
- No limit on prior central nervous system radiation or systemic therapy for all cohorts
- Karnofsky Performance Status (KPS) of 60 or higher
- Life expectancy greater than 12 weeks
- Adequate washout from prior therapies with recovery from any treatment-related toxicities before enrollment
- Adequate bone marrow, kidney, liver, and coagulation function within 7 days before starting study treatment: ANC ≥ 1.0 x 10^3/µL without recent granulocyte-colony stimulating factor use, platelet count ≥ 100,000/µL without recent transfusions or growth factor support, hemoglobin ≥ 7.0 g/dL (or ≥ 8 g/dL for gastric/gastroesophageal cancer) without recent transfusions or support, creatinine clearance ≥ 30 mL/min, AST and ALT ≤ 3 times upper limit of normal (≤ 5 times ULN for liver metastases), total bilirubin ≤ 1.5 times ULN (≤ 3 times ULN with Gilbert's syndrome or liver metastases)
You will not qualify if you...
- Known allergy or hypersensitivity to sotorasib or any of its components
- Multiple primary cancers within the last 3 years except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, smoldering pre-malignant or malignant conditions with minimal risk of progression, curatively treated in-situ disease, other curatively treated solid tumors, or contralateral breast cancer in metastatic breast cancer patients
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Nelson Moss, MD
CONTACT
C
Cameron Brennan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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