A Phase 2 Clinical Trial of Zanzalintinib in Patients With Unresectable and Progressive Metastatic Pheochromocytoma or Paraganglioma (MPPGs)
Dana-Farber Cancer Institute
Summary
This study is to examine the effects of oral daily zanzalintinib in participants with unresectable, progressive metastatic pheochromocytoma or paraganglioma.
Description
This is a Phase II, single-arm investigational study evaluating zanzalintinib in patients with unresectable and progressive metastatic pheochromocytoma or paraganglioma (MPPGs). Participants will receive zanzalintinib 60 mg orally once daily. Zanzalintinib is investigational and has not been approved by the U.S. Food and Drug Administration as a treatment for any disease. The research study procedures include: screening for eligibility; medical history; physical exams; vital signs; performance status assessments; tumor imaging with CT, MRI, or PET; blood tests; urine tests; pregnancy testing…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years. As no dosing or adverse event data are currently available in participants \< 18 years of age, children and adolescents are excluded from this study. * Documentation of Disease * Histologic Documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma. * Stage: Advanced (metastatic or unresectable primary) disease * Tumor Site: Histologically-proven pheochromocytoma or paraganglioma * Radiographic Evaluation: Radiographic evidence of disease progression by RECIST v1.1 criteria in the 12 month…
Interventions
- DrugZanzalintinib
Route: Oral Schedule: Daily
Locations (2)
- Brigham and Women's Hospital (BWH)Boston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts