Safety/efficacy of Everolimus in adults with advanced pancreatic neuroendocrine cancer not responsive to chemotherapy

An open label, stratified, single-arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy - NA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001247-64-SE

Enrollment

144

Registered

2006-05-12

Start date

2006-06-27

Completion date

Unknown

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced pancreatic neuroendocrine tumors (NET). MedDRA version: 14.1 Level: LLT Classification code 10033630 Term: Pancreatic islet cell neoplasm malignant NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Afinitor Product Name: RAD001 Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Advanced (unresectable or metastatic) biopsy-proven pancreatic NET •Confirmed low-grade or intermediate-grade neuroendocrine carcinoma •Objective disease progression by RECIST criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen) •Presence of at least one measurable disease using RECIST criteria at screening (CT or MRI) •Adequate bone marrow, liver and kidney function 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Patients with poorly differentiated neuroendocrine carcinoma •Hepatic artery embolization within the last 6 months •Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus) •Other concurrent malignancy •Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the objective response rate (ORR) (including complete response and partial response) of RAD001 10 mg po qd monotherapy in patients with advanced (unresectable or metastatic) pancreatic NETs after the failure of cytotoxic chemotherapy (stratum 1).;Secondary Objective: To determine: • response duration of RAD001 10 mg po qd monotherapy (stratum 1). • objective response rate (ORR) and response duration of RAD001 10 mg po qd plus Sandostatin LAR Depot therapy in patients whose tumors have progressed while receiving Sandostatin LAR Depot therapy and after the failure of cytotoxic chemotherapy (stratum 2). • safety and tolerability of RAD001 monotherapy (10 mg/d) in patients with Pancreatic NET (stratum 1). • safety and tolerability of the combination of RAD001 (10 mg/d) plus Sandostatin LAR Depot in patients with Pancreatic NET (stratum 2). • progression free survival (PFS) and the overall survival (OS) of patients receiving RAD001 10 mg per day in combination with Sandostatin LAR and of patients receiving RAD001 10 mg per day monotherapy. To assess the steady state exposure to RAD001 and to estimate the effect of co-administering Sandostatin LAR® Depot on RAD001 exposure.;Primary end point(s): Objective response rate	—

Measure

Time frame

Main Objective: To determine the objective response rate (ORR) (including complete response and partial response) of RAD001 10 mg po qd monotherapy in patients with advanced (unresectable or metastatic) pancreatic NETs after the failure of cytotoxic chemotherapy (stratum 1).;Secondary Objective: To determine: • response duration of RAD001 10 mg po qd monotherapy (stratum 1). • objective response rate (ORR) and response duration of RAD001 10 mg po qd plus Sandostatin LAR Depot therapy in patients whose tumors have progressed while receiving Sandostatin LAR Depot therapy and after the failure of cytotoxic chemotherapy (stratum 2). • safety and tolerability of RAD001 monotherapy (10 mg/d) in patients with Pancreatic NET (stratum 1). • safety and tolerability of the combination of RAD001 (10 mg/d) plus Sandostatin LAR Depot in patients with Pancreatic NET (stratum 2). • progression free survival (PFS) and the overall survival (OS) of patients receiving RAD001 10 mg per day in combination with Sandostatin LAR and of patients receiving RAD001 10 mg per day monotherapy. To assess the steady state exposure to RAD001 and to estimate the effect of co-administering Sandostatin LAR® Depot on RAD001 exposure.;Primary end point(s): Objective response rate

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Countries

Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026