Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor (\MACS1304)

Novartis

Status and phase: Completed; Phase 1

Conditions: Lung Neuroendocrine Neoplasm

Treatments: Drug: RAD001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324492

CRAD001KCN01

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

RAD001

Experimental group

Treatment:

Drug: RAD001