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RAD001 in Pheochromocytoma or Nonfunctioning Carcinoid

NCT01152827 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-05-20

No results posted yet for this study

Summary

* According to Martin F et al, AKT is highly phosphorylated in phenochromocytoma but not in benign adrenocortical tumors.
* In nonfunctioning carcinoid, the PI3K/AKT/mTOR pathway is activated.
* Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 have been conducted in pheochromocytoma or extra-adrenal paraganglioma or non-functioning carcinoid.
* So we design this phase II study of RAD001 in pheochromocytoma or extra-adrenal paraganglioma or non-functioning carcinoid to evaluate the efficacy of RAD001 in this orphan disease.

Conditions

  • Pheochromocytoma
  • Extra-adrenal Paraganglioma
  • Non-functioning Carcinoid

Interventions

DRUG

RAD001

RAD001 10 mg daily po medication. Treatments will be continued until any of the following events occur * progression of disease * the subject develops unacceptable toxicity * consent to participate in the study is withdrawn

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yung-Jue Bang, MD, PhD · Seoul National University Hospital

  • Do-Youn Oh, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-05-31
Completion
2011-12-31

Countries

  • South Korea

Study Locations

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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 NCT01152827 on ClinicalTrials.gov