A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Phase 1
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Both
Lung Neuroendocrine Neoplasm
Both
Lung Neuroendocrine Neoplasm
Trial Information
A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
every 6 weeks
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001KCN01
NCT ID:
NCT01324492
Start Date:
December 2010
Completion Date:
July 2015
Related Keywords:
- Lung Neuroendocrine Neoplasm
- phase Ib,
- RAD001,
- advanced pulmonary neuroendocrine tumor
- Neoplasms
- Neuroendocrine Tumors
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