| Exclusion Criteria |
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Participants with primary brain tumors or disease metastatic to the brain.
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For participants with leukemia, has overt central nervous system (CNS) disease (CNS 3 status).
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Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
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Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
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CAR-T infusion or other cellular therapy within 30 days
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Anticancer therapy including blinatumomab or chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter
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Steroid therapy for anti-neoplastic intent within 5 days
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Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
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Participants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.
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Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy.
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Participants who have received the following within 7 days prior to the first dose of study drug:
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Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose Determination);
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Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort Expansion).
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Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
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Participants who have active, uncontrolled infections.
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Participants with malabsorption syndrome or any other condition that precludes enteral administration.
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Groupe d'étude en oncologie du Québec