EUCTR2011-002872-17-GB
Active, not recruiting
Phase 1
Multicenter 3-arm 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 -LUNA Trial
Conditionseouroendocrine carcinoma of the lung and thymusMedDRA version: 20.0Level: LLTClassification code 10025064Term: Lung carcinomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAfinitor®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- eouroendocrine carcinoma of the lung and thymus
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 124
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological confirmed advanced typical and atypical carcinoid tumours of the lung and thymus
- •Patients of all treatment lines can be enrolled
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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