Brain Tumor
Conditions
Keywords
SOTORASIB, KRAS G12C, CNS-BRAIN, Advanced, 24-111
Brief summary
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.
Interventions
DRUGSotorasib
Enrolled patients will be administered DCOI at the FDA-recommended dose or continued on the DCOI at the discretion of the treating Oncologist per standard of care
Sponsors
Memorial Sloan Kettering Cancer Center
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be separated into cohorts based on wether they are drug/combination of interest (DCOInaïve) or have progressed on the DCOI.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy * Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy * For all cohorts: no limit on prior CNS radiation or systemic therapyKPS ≥ 60 * Life expectancy \>12 weeks * Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator * Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment): * Absolute neutrophil count (ANC) ≥1.0 × 10\^3/μL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1) * Platelet count ≥10.0x10\^4/μL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x10\^4/μL are not eligible. (Platelet transfusion is not allowed within 1 week prior to C1D1) * Hemoglobin ≥ 7.0 g/dL (≥ 8 g/dL in gastric cancer / gastroesophageal cancer indications). Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible (Red blood cell transfusion is not allowed within 1 week prior to C1D1) * Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (\<5x ULN in participants with liver metastases) * Total bilirubin ≤1.5 × ULN) if no liver metastases or \<3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline
Exclusion criteria
* Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the Principal Investigator; reactions will be managed per standard institutional protocol * Multiple primary malignancies within 3 years, with the exception of: * adequately resected non-melanoma skin cancer * carcinoma in situ of the cervix * Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider * curatively treated in-situ disease * other solid tumors curatively treated * for patients with metastatic breast cancer: contralateral breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR (overall response rate) | 1 year | defined as the sum of CR (complete response) rate plus PR (partial response) rate, assessed by RECIST 1.1. |
Countries
United States
Contacts
CONTACTNelson Moss, MD
CONTACTCameron Brennan, MD
PRINCIPAL_INVESTIGATORNelson Moss, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed