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NCT03946527 · ClinicalTrials.gov registry record · Phase 2
LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)
A Phase 2 study of Pheochromocytoma and Paraganglioma, sponsored by Antonio Fojo.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT03946527: Active Phase 2 study of Pheochromocytoma and Paraganglioma, sponsored by Antonio Fojo.
NCT03946527 is a Phase 2 study of Pheochromocytoma and Paraganglioma that is active but no longer recruiting, run by Antonio Fojo. The registered enrollment target is 10 participants, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03946527, a Phase 2 study of Pheochromocytoma and Paraganglioma, is active but no longer recruiting, sponsored by Antonio Fojo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Efficacy will be assessed by measuring the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrollment growth rates. Tumor growth measured by a CT or MRI scan in pre-treatment, and minimum of three scans (prior to every 3rd visit, or every 12 weeks) in post-treatment.
Conditions Studied
Interventions
- DRUG Lanreotide
Study Locations (2)
New York
- Columbia University Irving Medical Center - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT03946527 still lists
NCT03946527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Pheochromocytoma appearing as the primary indexed condition, and to 1 intervention - of which Lanreotide is the first listed.
NCT03946527 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT03946527 about?
NCT03946527 is a clinical study titled "LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)". 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. * ...
What is the current status of trial NCT03946527?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-06-17. Estimated completion is 2027-03.
What conditions does trial NCT03946527 study?
This clinical trial studies the following conditions: Pheochromocytoma, Paraganglioma.
What interventions are being tested in trial NCT03946527?
The interventions under investigation include: Lanreotide (DRUG).
Who is sponsoring clinical trial NCT03946527?
This trial is sponsored by Antonio Fojo, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03946527 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03946527's enrollment target sits among peer trials
10 14th of 14 higher than 1 of 14 other Pheochromocytoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pheochromocytoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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