Venetoclax and Irinotecan in Relapsed/Refractory SCLC

Exclusion Criteria

• •Ongoing requirement for any non-study anticancer therapy
• •Ongoing or planned treatment with any of the following:
• •* Greater than 10 mg prednisone daily or equivalent
• •* Immunosuppressive agents
• •* Strong or moderate CYP3A inhibitor or inducer, or a narrow-therapeutic sensitive substrate
• •* P-gp inhibitor or narrow-therapeutic sensitive P-gp substrate If any of these agents have been used, patients must be off them for ≥ 1 week before initiation of study treatment.
• •Any investigational agent within 21 days prior to the first dose of the investigational drugs
• •Has consumed grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before initiation of study treatment.
• •Phase 2 portion only: Previous systemic anticancer therapy other than platinum-based therapy
• •Known leptomeningeal metastases
• •Known untreated brain metastases
• •Hypersensitivity to irinotecan, venetoclax, or their excipients
• •Diarrhea ≥ grade 1
• •Ongoing need for antidiarrheal agents
• •Active uncontrolled infection, ongoing or within 2 weeks before initiating treatment
• •Known homozygosity for the UGT1A1\*28 allele Note: Study-specific UGT1A1 testing is not required
• •Inability to swallow oral medications and/or malabsorption
• •Pregnancy or breastfeeding
• •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements