NCT03008369

Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery

Phase II Trial of Lenvatinib in Metastatic or Advanced Pheochromocytoma and Paraganglioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well lenvatinib works in treating patients with pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be removed by surgery. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the anti-tumor activity of lenvatinib (overall response rate; \[ORR\]) in patients with metastatic or advanced unresectable pheochromocytomas and paragangliomas. SECONDARY OBJECTIVES: I. To determine progression-free survival (PFS). II. To determine overall survival (OS). III. To determine duration of tumor response. IV. To determine safety and tolerability of lenvatinib. V. To assess patient reported quality of life using EuroQol Five-Dimensional Five Level Scale Questionnaire (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G). TERTIARY OBJECTIVES: I. For patients with secretory tumors, to examine changes in plasma metanephrine levels and urinary catecholamine and/or metanephrine levels. II. For patients with secretory tumors, to examine whether lenvatinib-induced changes in plasma metanephrines and urinary catecholamine and/or metanephrine levels during the first cycle of treatment may be associated with objective tumor response. III. To examine associations between tumor response and somatic mutational status in archived tumors, or germline mutational status (presence of SDHD, SDHB, RET, VHL, neurofibromatosis type-1). OUTLINE: Patients receive lenvatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 or 6 months for up to 5 years.

Conditions

• Malignant Adrenal Gland Pheochromocytoma
• Malignant Paraganglioma
• Metastatic Adrenal Gland Pheochromocytoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenvatinib	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2017-05-31
• Primary completion: 2020-12-01
• Completion: 2022-09-28
• First posted: 2017-01-02
• Last updated: 2024-02-20
• Results posted: 2021-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study