LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The objectives of this study are:
- To assess the efficacy of lanreotide given every 4 weeks in participants with advanced
or metastatic paraganglioma/ pheochromocytoma.
- To assess the toxicity and safety of lanreotide in participants with advanced or
metastatic paraganglioma/ pheochromocytoma.
- To document the effects of lanreotide on markers of biochemical activity in participants
with advanced or metastatic paraganglioma/ pheochromocytoma.
Primary endpoints:
• Assess efficacy by estimating the tumor growth rate while a patient is enrolled on study
and comparing the growth rates on lanreotide to the pre-enrolment growth rate.
Secondary endpoints include measurement of:
- Overall survival (OS)
- Progression-free survival (PFS)
- Overall response rate (ORR) according to RECIST defined as partial response (PR) +
complete response (CR)
- Magnitude of reduction in levels of 24-hour urinary metanephrines, catecholamines and
magnitude of reduction in serum chromogranin A, evaluated every two months while
enrolled on study.