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

• Register: EUCTR
• Last refreshed on: 16 October 2012
• Main ID: EUCTR2006-001247-64-SE
• Date of registration: 12/05/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Safety/efficacy of Everolimus in adults with advanced pancreatic neuroendocrine cancer not responsive to chemotherapy
• Scientific title: 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
• Date of first enrolment: 27/06/2006
• Target sample size: 144
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001247-64
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

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

Key inclusion & exclusion 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:
•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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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)

Intervention(s)

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 milligram(s)
Concentration type: equal
Concentration number: 5.0-

Trade Name: add local trade name of Sandostatin LAR
Product Name: add local trade name Sandostatin LAR
Product Code: SMS995
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: octreotide
CAS Number: 79517-01-4
Current Sponsor code: SMS995
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Sandostatin LAR
Product Name: add local trade name of Sandostatin LAR
Product Code: SMS995
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: octreotide
CAS Number: 79517-01-4
Current Sponsor code: SMS995
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: add local trade name Sandostatin LAR
Product Name: add local trade name of Sandostatin LAR
Product Code: SMS995
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: octreotide
CAS Number: 79517-01-4
Current Sponsor code: SMS995
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

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.

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).

Primary end point(s): Objective response rate

Secondary ID(s)

CRAD001C2239

Source(s) of Monetary Support

Novartis Pharma Services AG