Clinical trial to evaluate the efficacy and safety of Pasireotide LAR or Everolimus alone or in combination in patients with well differentiated neuroendocrine carcinoma of the lung and thymus
- Conditions
- eouroendocrine carcinoma of the lung and thymusMedDRA version: 17.1Level: LLTClassification code 10025064Term: Lung carcinomaSystem Organ Class: 100000004864MedDRA version: 17.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002872-17-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 124
•Histological confirmed advanced well differentiated carcinoma of the lung and thymus
•Patients of all treatment lines can be included
•At least one measurable lesion of disease on CT scan or MRI
•Radiological documentation of disease progression within 12 months prior to randomization
•Adequate liver, renal and bone marrow function
•WHO Performance Status 0-2
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
•Poorly differentiated neuroendocrine carcinoma
•Non-neuroendocrine thymoma
•Patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
•Prior therapy with mTOR inhibitors
•History of liver disease
•Baseline QTcF> 470 msec
•Uncontrolled diabetes mellitus despite adequate therapy
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method