Cancer, Pediatric Cancer
Conditions
Keywords
Solid tumors, Brain tumors, Nervous system tumors, Relapsed, Refractory, Sarcoma and/or osteosarcoma, Central nervous system (CNS), Neuroendocrine tumors, Progressed, Brain
Brief summary
The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
Interventions
DRUGZanzalintinib
Administered as specified in the treatment arm.
Sponsors
Exelixis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants must be \< 17 years old. * Participants must have a minimum body weight of ≥ 10 kilograms (kg) at enrollment. * Performance status of ≥ 50% as measured by Lansky for participants \< 16 years of age or Karnofsky for participants ≥ 16 years of age. * Have a relapsed or refractory solid tumor, including primary CNS tumors (excluding lymphoma). Key
Exclusion criteria
* For participants with CNS primary tumors, evidence of intracranial or intratumoral hemorrhage are excluded. * Diagnosis of lymphoma. * Lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) | Up to Day 28 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve (AUC) of Zanzalintinib | From Week 1 Day 1 to Week 21 Day 1 |
| Maximum Plasma Concentration (Cmax) of Zanzalintinib | From Week 1 Day 1 to Week 21 Day 1 |
| Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib | From Week 1 Day 1 to Week 21 Day 1 |
Contacts
CONTACTExelixis Clinical Trials
STUDY_DIRECTORMedical Director
Exelixis
Outcome results
None listed