An open label, stratified, single-arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy
- Conditions
- advanced islet cell carcinomaadvanced pancreatic neuroendocrine tumor1002911210014713
- Registration Number
- NL-OMON29869
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
* Advanced (unresectable or metastatic) biopsy-proven pancreatic neuroendocrine tumor.
* Pancreatic neuroendocrine tumor with documented objective progression of disease while receiving cytotoxic chemotherapy or documented progression at any time after receiving an adequate course of cytotoxic chemotherapy
* At screening a CT or MRI scan must demonstrate measurable disease
* Adequate liver function: bilirubin <= 1.5 x ULN; ALT and AST <= 2.5x ULN ( <= 5x ULN in patients with liver metastases).
* Stratum 1: Not receiving Sandostatin LAR <= 30 days of enrollment
* Stratum 2 only: receiving treatment (at least 3 consecutive months) with Sandostatin LAR Depot.
* Anticancer therapy within 3 weeks of enrollment
* Hepatic artery embolization within the last 6 months, or cryoablation of hepatic metastasis within 2 months of enrollment.
* Prior therapy with RAD001 (everolimus) or other rapamycins
* Uncontrolled diabetes
* Chronic active or persistent liver disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>objective response rate (ORR) (complete response and partial response) of<br /><br>RAD001 10 mg po qd monotherapy in patients with advanced (unresectable or<br /><br>metastatic) pancreatic NET after the failure of cytotoxic chemotherapy (stratum<br /><br>1).</p><br>
- Secondary Outcome Measures
Name Time Method