This trial is active, not recruiting.

Condition lung neuroendocrine neoplasm
Treatment rad001
Phase phase 1
Targets mTOR, FKBP-12
Sponsor Novartis Pharmaceuticals
Start date December 2010
End date July 2015
Trial size 16 participants
Trial identifier NCT01324492, CRAD001KCN01


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
rad001 Everolimus

Primary Outcomes

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
time frame: every 6 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Novartis.