Lanreotide for Pheochromocytoma / Paraganglioma

(LAMPARA Trial)

Recruiting at 2 trial locations

Overseen by Antonio Fojo, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Antonio Fojo

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Antonio Fojo, MD, PhD

Principal Investigator

Columbia University

Eligibility Criteria

Adults with advanced or metastatic paraganglioma/pheochromocytoma, who have shown recent disease progression and are somatostatin receptor positive. They must be in good enough health to participate (ECOG 0-2), not pregnant, willing to use contraception if of childbearing potential, and have a life expectancy over 12 weeks. Prior treatments like surgery should be completed at least 28 days before joining.

Inclusion Criteria

You are able to carry out everyday activities without needing help.

Male or female at least 18 years of age at the time of first dosing

Patients must give signed informed consent before any study-related activities are conducted

Exclusion Criteria

Any serious medical condition that could jeopardize the safety of the patient and/or the efficacy assessments of the study

You have had a heart attack, unstable chest pain, or worsening heart failure in the last 28 days.

You have a known allergy to the investigational drug or similar medications like Lanreotide or octreotide.

Treatment Details

Interventions

• Lanreotide (Somatostatin Analog)

Trial Overview The trial is testing the effectiveness and safety of lanreotide administered every four weeks on patients with pheochromocytoma/paraganglioma. It will compare tumor growth rates before and after treatment, survival times without disease progression, response rates to treatment, and changes in specific biochemical markers.

Participant Groups

Group I: lanreotide arm Experimental Treatment 1 Intervention

Patients with a histopathologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability who meet the inclusion/exclusion criteria. Approximately 40 patients will be enrolled.

Who Is Running the Clinical Trial?

Antonio Fojo

Lead Sponsor

Trials

3

Recruited

20+

Ipsen

Industry Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD