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: 16.1Level: LLTClassification code 10025064Term: Lung carcinomaSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

- Histological confirmed advanced well differentiated carcinoma of the lung and thymus
- Patients of all treatment lines including naive patients 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
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.<br>;Secondary Objective: Progression-free survival<br>Disease control rate<br>Time to Response<br>Duration of Response<br>Time from onset of the first objective tumor response<br>Time to progression<br>Biochemical response rate<br>Safety and Tolerability;Primary end point(s): Proportion of patients progression-free at 12 months;Timepoint(s) of evaluation of this end point: 12 months