Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

Phase 1

Completed

• Conditions: Lung Neuroendocrine Neoplasm
• Interventions: Drug: RAD001

• Registration Number: NCT01324492
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-26
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Histologically confirmed carcinoid tumors
• Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible

Exclusion Criteria

• Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible)
• Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment
• Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer
• Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus)

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAD001	RAD001	-

Primary Outcome Measures

Name	Time	Method
Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis	every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria	6 weeks
Date and reason of death, or discontinuation from the study.	12 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Shenyang, Liaoning, China