Non-Hodgkin lymfomen, neuroblastoom en overige solide tumoren AML/ALL/NHL/Neuroblastoma Pediatric cancer
Conditions
Interventions
Administration of venetoclax.
Sponsors
AbbVie B.V.
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be = 18 years of age may be halted at any time during the study to ensure adequate enrollment of pediatric patients (= 60 mL/min/1.73 m2. 5. Patients = 50% and patients > 16 years of age must have performance status of Karnofsky >= 50%. 6. In Part I, patients with solid tumors (with the exception of neuroblastoma) must have adequate bone marrow function as defined by ANC >= 1000/µl and platelets > 75,000/µl (with transfusion independence defined as not receiving platelet transfusion within 7 days prior to enrollment). 7. For the fifth cohort during Part 2, patients with solid tumors must have evidence of BCL-2 expression.
Exclusion criteria
Exclusion criteria: 1. Patients with primary brain tumors or disease metastatic to the brain. 2. Patients who have CNS disease with cranial involvement that requires radiation. 3. Patients who have received any of the following within the listed time frame, prior to the first dose of study drug - Inotuzumab ozogamicin within 30 days - Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days - CAR-T infusion or other cellular therapy within 30 days - Anticancer therapy including blinatumomab or chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter - Exceptions: Ph+ ALL subjects on TKIs at Screening may enroll and remain on TKI therapy to control disease. - Steroid therapy for anti-neoplastic intent within 5 days - Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose) 4. Patients who are less than 100 days post-transplant, or >= 100 days post-transplant with active GVHD, or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug. 5. Patients who are less than 6 weeks post-131 I-mIBG therapy. 6. Patients who have received the following within 7 days prior to the first dose of study drug: - Strong and moderate CYP3A inhibitors (Part 1); - Strong and moderate CYP3A inducers (Part 1 and Part 2). 7. Patients who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy. 8. Patients who have active, uncontrolled infections. 9. Patients with malabsorption syndrome or any other condition that precludes enteral administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Safety will be assessed by evaluating study drug exposure, adverse events, serious adverse events, deaths, and changes from baseline in laboratory determinations. Safety summaries will be provided for Part 1 and Part 2 separately and overall, and by dose level, tumor type and combination therapy (venetoclax in combination with chemotherapy). Pharmacokinetic: Plasma concentrations of venetoclax (and metabolite(s)) and pharmacokinetic parameter values will be tabulated for each patient and each dose level. Summary statistics will be provided for each sampling time and each parameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Objective Response Rate - Complete Response Rate - Partial Response Rate | — |
Countries
Netherlands
Outcome results
None listed