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First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma

NCT01371201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-08-04

No results posted yet for this study

Summary

The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter study which aims to determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).

Conditions

  • Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)

Interventions

DRUG

Sunitinib

sunitinib 37.5 mg per day

DRUG

Placebo

Placebo 37.5 mg per day

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • European Network for the Study of Adrenal Tumours

    collaborator UNKNOWN

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Eric Baudin, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-22
Primary Completion
2013-10-01
Completion
2021-04-20

Countries

  • France
  • Germany
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT01371201 on ClinicalTrials.gov