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Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

NCT01175096 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-08-04

No results posted yet for this study

Summary

RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act:

* directly on the tumor cells by inhibiting tumor cell growth and proliferation
* indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells)

A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001).

The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.

Conditions

Interventions

DRUG

RAD001 (everolimus, Afinitor®)

RAD001 will be provided by Novartis to the study sites. RAD001 is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 30 tablets. The study site will dispense an adequate supply of RAD001 to the patient for self-administration at home. 2 x 5 mg (=10 mg) RAD001 p.o., once daily, at the same time each day, One treatment cycle consists of 28 days.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Yilong Wu, MD.PhD · Guangdong Provincial People's 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
2010-07-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • China

Study Locations

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Entities

Diseases
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 NCT01175096 on ClinicalTrials.gov