Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
\MACS1304
A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
1 other identifier
interventional
16
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2010
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 30, 2014
December 1, 2014
3.5 years
March 24, 2011
December 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
RAD001
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed carcinoid tumors
- Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Novartis Investigative Site
Beijing, Beijing Municipality, 100730, China
Novartis Investigative Site
Guangzhou, Guangdong, 510030, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Shenyang, Liaoning, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Investigative Site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 29, 2011
Study Start
December 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 30, 2014
Record last verified: 2014-12