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

Phase 1

• Conditions: Well differentiated neouroendocrine carcinoma of the lung and thymus; MedDRA version: 14.1 Level: LLT Classification code 10025064 Term: Lung carcinoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 14.1 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864

• Registration Number: EUCTR2011-002872-17-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

•Histological confirmed advanced well differentiated neuroendocrine 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 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with well differentiated neuroendocrine tumor of the lung and thymus defined as the proportion of patients progression fall at 12 months<br> ;<br> Secondary Objective: Progression-free survival<br> Disease control rate<br> Time to Response<br> Duration of Response<br> Time to progression<br> Biochemical response rate<br> Safety and Tolerability<br> ;Primary end point(s): Proportion of patients progression-free at 12 months;Timepoint(s) of evaluation of this end point: 12 months