Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-17
SponsorExelixis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Zanzalintinib
DrugAdministered as specified in the treatment arm.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: ZanzalintinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame
Up to Day 282
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame
Up to 8 monthsSecondary outcomes
1
Area Under the Concentration-Time Curve (AUC) of Zanzalintinib
Time frame
From Week 1 Day 1 to Week 21 Day 12
Maximum Plasma Concentration (Cmax) of Zanzalintinib
Time frame
From Week 1 Day 1 to Week 21 Day 13
Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib
Time frame
From Week 1 Day 1 to Week 21 Day 1Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: