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LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

NCT03946527 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Paraganglioma
  • Pheochromocytoma

Interventions

DRUG

Lanreotide

Participants will receive lanreotide 120 mg deep subcutaneous injection every 4 weeks (±7 days) for 52 weeks, followed by an extension phase in which all patients will continue to receive lanreotide 120 mg injection every 4 weeks (±7 days) if there is no evidence of disease progression.

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Antonio Fojo

    lead OTHER

Principal Investigators

  • Antonio Fojo, MD, PhD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946527 on ClinicalTrials.gov