Status:
UNKNOWN
Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
Novartis
Conditions:
Neuroendocrine Tumors
Carcinoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its pot...
Detailed Description
The purpose of this phase I b study is to characterize the safety, tolerability, and efficacy of 10 mg RAD001 administered orally on a continuous once-daily dosing regimen in the treatment of advanced...
Eligibility Criteria
Inclusion
- For carcinoid tumor
- Histologically confirmed carcinoid tumors
- Newly diagnosed advanced carcinoid tumors
- Measurable tumors
- Chinese men and women, age ≥ 18 years
- ECOG performance status ≤ 2
- Written informed consent obtained
Exclusion
- 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)
- Major surgery in the past two weeks
- Any medical condition resulting in \>CTC grade 2 dyspnea
- Patients with recent hemoptysis associated with carcinoid tumor (\> 1 teaspoon in a single episode within 4 weeks)
- Serious, severe or uncontrolled medical or psychiatric condition
- Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
- Patients with a known history of HIV seropositivity
- Women of childbearing potential must have had a negative serum pregnancy test within 3 days prior to the administration of RAD001
- Patients who have received an investigative drug or therapy within the last 30 days
- For adenocarcinoma and Large cell lung cancer with significant neuroendocrine carcinoma characteristics
- Inclusion Criteria:
- Histologically confirmed locally unresectable or advanced well differentiated （adenocarcinoma,squamous cancer and large cell lung cancer ）with significant neuroendocrine carcinoma characteristics tumors : CgA and/or Synaptophysin +(at least 10% of cells that would have to be positive ).( the pathology shows a neuroendocrine component histologically should be at least 10% of tissue within the specimen that is read as "neuroendocrine component").
- Measurable tumors
- Patients with newly diagnosed advanced cancer or progressed after 1st line treatment is eligible
- Chinese men and women, age ≥ 18 years
- ECOG performance status ≤ 2
- Written informed consent obtained
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01175096
Start Date
July 1 2010
End Date
January 1 2012
Last Update
August 4 2010
Active Locations (1)
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1
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080