A study of everolimus plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced neuroendocrine cancer of gastrointestinal or lung origi

Phase 1

• Conditions: Advanced neuroendocrine tumor (NET) of GI or lung origin; MedDRA version: 20.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002887-26-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: 2012-02-29
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

1.Pathologically confirmed, well differentiated (G1 or G2), advanced
(unresectable or metastatic), neuroendocrine tumor of GI or lung origin.
2.No history of and no active symptoms related to carcinoid syndrome
(or other hypersecretory syndromes).
3.Patients treated with prior SSA and/or Interferon (IFN) may be
included. These patients must discontinue treatment prior to the day of
randomization as follows:
4.Radiological documented disease progression within 6 months prior to
randomization
5.Measurable disease
6.WHO performance status =1
7.Adequate bone marrow, lifer and renal function
Other protocol-defined inclusion/exclusion 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

1.Patients with poorly differentiated neuroendocrine carcinoma, highgrade
neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell
carcinoma, gastrinoma, goblet cell carcinoid, and small cell carcinoma.
2.Patients with pancreatic NET or NET of origins other than GI or lung
3.Patients with history of or active symptoms of carcinoid syndrome
(e.g. flushing, diarrhea).
4.More than one prior line of chemotherapy;
5. Prior targeted therapy;
6.Hepatic intra-arterial embolization within the last 6 months (or 1
month if there is measurable disease in other organs besides the liver)
7.Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus,
deforolimus).
8.Known intolerance or hypersensitivity to everolimus or other
rapamycins (e.g. sirolimus, temsirolimus).
9.Impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of oral everolimus.
10.Uncontrolled diabetes mellitus.
11.Patients who have any severe and/or uncontrolled medical conditions
such as:
•unstable angina pectoris, symptomatic congestive heart failure,
myocardial infarction =6 months prior to randomization, serious
uncontrolled cardiac arrhythmia;
•active or uncontrolled severe infection;
•liver disease such as cirrhosis, decompensated liver disease, and
chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg,
quantifiable HCV-RNA).
12.Chronic treatment with corticosteroids or other immunosuppressive
agents.
13.Known history of HIV seropositivity.
14.Pregnant or nursing (lactating) women, where pregnancy is defined
as the state of a female after conception and until the termination of
gestation, confirmed by a positive hCG laboratory test

Study & Design

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