Lung Neuroendocrine Neoplasm Clinical Trial
— \MACS1304Official title:
A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Novartis Investigative Site | Beijing | Beijing |
China | Novartis Investigative Site | Changchun | Jilin |
China | Novartis Investigative Site | Guangzhou | Guangdong |
China | Novartis Investigative Site | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria | 6 weeks | No | |
Secondary | Date and reason of death, or discontinuation from the study. | 12 weeks | No |
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