EUCTR2011-002872-17-SE
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
DrugsAfinitor®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 124
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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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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 thymuseouroendocrine 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]EUCTR2011-002872-17-GBovartis Pharma Services AG124