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

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2006-001247-64-IT
• Date of registration: 16/04/2007
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public 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
• 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
• Date of first enrolment: 24/05/2006
• 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: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, Germany, Italy, Netherlands, Spain, Sweden

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

• Name: Drug Regulatory Affairs
• Affiliation: NOVARTIS FARMA

Key inclusion & exclusion criteria

Inclusion criteria:
Adult male or female patients (>=18 years of age). 2. Advanced (unresectable or metastatic) biopsy-proven pancreatic NET documented as follows: ? Radiologic, operative, or pathology reports should document a pancreatic location of tumor at some point in the patient's history; ? Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Pathology report should state one of the following: carcinoid, islet cell carcinoma, pancreatic endocrine tumor, low-grade or well-differentiated neuroendocrine carcinoma, atypical carcinoid, intermediate-grade or moderately differentiated neuroendocrine carcinoma; ? Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma are not eligible. 3. Documented objective progression of disease by RECIST criteria while receiving cytotoxic chemotherapy or documented progression 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). Previous therapy with alpha interferon or tyrosine kinase inhibitors are allowed but would not be considered to be prior chemotherapy. Objective progression of disease must be documented by RECIST criteria. Any of the following would be sufficient according to RECIST: ? a 20% increase in the sum of unidimensionally measured target lesions; ? a new lesion; ? unequivocal increase in non -measurable disease.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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:
Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, surgery or radiotherapy. Investigational agents used solely for imaging purposes are permissible if deemed safe and acceptable by local review authorities. Sandostatin LAR Depot is allowed in stratum 2. 2. Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation of hepatic metastasis within 2 months of enrollment. 3. Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus). 4. Patients with uncontrolled diabetes mellitus as defined by fast blood sugar > 1.5 x ULN. 5. Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. 6. Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy. 7. 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 five years. 8. Known history of immunocompromise, including a positive HIV test. An HIV test will not be required; however, previous medical history will be reviewed. 9. Pregnant or nursing (lactating) women. Unless demonstrated to be post-menopausal (see inclusion criteria), pregnancy should be excluded by serum pregnancy test. 10. Concomitant medications known to inhibit, induce or be a substrate to isoenzyme CYP3A are excluded unless the drugs are medically necessary and no substitutes are available. If there are no acceptable substitutes, special precautions should be taken in these patients.


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

Health Condition(s) or Problem(s) studied

pancreatic neuroendocrine tumor (NET)
MedDRA version: 14.1 Level: PT Classification code 10055007 Term: Carcinoid tumour of the pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: SANDOSTATINA LAR*FL 10MG+SIR+2
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Octreotide
CAS Number: 83150-76-9
Concentration unit: mg milligram(s)
Concentration number: 10-

Trade Name: SANDOSTATINA LAR*FL 20MG+SIR+2
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Octreotide
CAS Number: 83150-76-9
Concentration unit: mg milligram(s)
Concentration number: 20-

Trade Name: SANDOSTATINA LAR*FL 30MG+SIR+2
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Octreotide
CAS Number: 83150-76-9
Concentration unit: mg milligram(s)
Concentration number: 30-

Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: -the response duration of RAD001 10 mg po qd monotherapy (stratum 1). ?the 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 coadministering Sandostatin LAR Depot on RA

Primary end point(s): Objective response rate (CR + PR)

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 ID(s)

CRAD001C2239

2006-001247-64-SE

Source(s) of Monetary Support

Novartis Pharma Services AG