A randomized double-blind phase III study of RAD001 10 mg/d plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced pancreatic neuroendocrine tumor (NET) - N/A

• Conditions: Pancreatic neuroendocrine tumors(also called pancreatic endocrine tumors or islet cell tumors (ICT)); MedDRA version: 9.1Level: LLTClassification code 10033630Term: Pancreatic islet cell neoplasm malignant NOS

• Registration Number: EUCTR2006-006819-75-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-27
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
2. Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
3. Patients must have radiological documentation of progression of disease within 12 months prior to randomization. If patient received anti-tumor therapy during the past 12 months, he/she must have radiological documentation of progression of disease while on or after receiving the therapy
4. Measurable disease per RECIST criteria using Triphasic Computed Tomography (CT) scan or multiphase MRI for radiologic assessment
5. Adequate bone marrow function as shown by: ANC = 1.5 x 109/L, Platelets = 100 x 109/L, Hemoglobin >9 g/dL
6. Adequate liver function as shown by:
• Serum bilirubin = 1.5 x ULN
• INR < 1.3 (INR < 3 in patients treated with anticoagulants)
• ALT and AST = 2.5 x ULN (= 5x ULN in patients with liver metastases)
7. Adequate renal function: serum creatinine = 1.5 x ULN
8. Fasting serum cholesterol = 300 mg/dL OR = 7.75 mmol/L AND fasting triglycerides = 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
9. Performance Status 0-2 on the WHO scale
10. Adult male or female patients = 18 years of age
11. Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and /or urine pregnancy test 48 hours prior to the administration of the first study treatment
12. Written informed consent from patients must be obtained in accordance to local guidelines
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma are not eligible
2. Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to randomization
3. Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment
4. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus).
5. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN
6. 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
• cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air).
• active, bleeding diathesis
7. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
8. Patients with a known history of HIV seropositivity
9. No other prior or concurrent malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for = 3 years.
10. Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes

Study & Design

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