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)

Phase 3

Completed

• Conditions: advanced pancreatic neuroendocrine tumor; 10029112

• Registration Number: NL-OMON30904
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

- Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
- Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- 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
- Measurable disease per RECIST criteria.
- Adequate bone marrow, liver and renal function.
- Fasting serum cholesterol * 300 mg/dL OR * 7.75 mmol/L AND fasting triglycerides * 2.5 x ULN.

Exclusion Criteria

- Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma.
- Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to
randomization.
- 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.
- Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- Uncontrolled diabetes mellitus.
- Patients who have any severe and/or uncontrolled medical conditions.
- Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent.
- Patients with a known history of HIV seropositivity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression Free Survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Objective Response Rate and Response Duration, Overall Survival, safety and<br /><br>tolerability of RAD001, pharmacokinetics of RAD001, tumormarkers, angiogenesis<br /><br>biomarkers, immunohistochemical and genetic mTOR pathway characterization on<br /><br>pre-treatment tumor material.</p><br>