This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days.
Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib.
A maximum of 25 cycles (2 years) of alectinib may be administered on study.
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Fluent English skills with comprehensive/speaking skills equal to those of a native English speaker as assessed by the site investigator.
ECOG Performance Status of ≤ 2 within 14 days prior to registration.
Active infection requiring systemic therapy.
Malabsorption syndrome or other condition that would interfere with enteral absorption
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
Joshua Palmer
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Genentech, Inc.
Collaborator