A Study of Sotorasib in People With Brain Tumors
ConditionBrain Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sotorasib
DrugEnrolled 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
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: DCOI naïveExperimental treatment 1 intervention
Group B: Progressed on the DCOIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ORR (overall response rate)
defined as the sum of CR (complete response) rate plus PR (partial response) rate, assessed by RECIST 1.1.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Amgen
Collaborator
Source ClinicalTrials.gov