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: eouroendocrine carcinoma of the lung and thymus; MedDRA version: 20.0Level: LLTClassification code 10025064Term: Lung carcinomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-19
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

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
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

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
Main Objective: To evaluate the efficacy of pasireotide LAR and everolimus alone or in<br>combination in progressive patients with a well differentiated<br>neuroendocrine tumor of the lung or thymus.;Secondary Objective: Progression-free survival<br>Disease control rate<br>Time to Response<br>Duration of Response<br>Biochemical response rate<br>Rate and severity of AEs;Primary end point(s): Proportion of patients progression-free at 9 months;Timepoint(s) of evaluation of this end point: 9 months