An expanded access study of everolimus in patients with advanced neuroendocrine tumors.
- Conditions
- The study will evaluate the safety of everolimus in patients with advanced neuroendocrine tumors of gastrointestinal, lung or pancreatic origin.MedDRA version: 14.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023032-17-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1. Age = 18 years old; 2. Advanced (unresectable or metastatic) biopsy-proven neuroendocrine tumor of gastrointestinal, lung or pancreatic origin; 3. Performance Status 0-2 on the WHO scale; 4. Adequate bone marrow function as shown by: • ANC = 1.5 x 109/L, • Platelets = 100 x 109/L, • Hemoglobin >9 g/dL; 5. Adequate liver function as shown by: • Serum bilirubin = 1.5 x ULN, • ALT and AST = 2.5 x ULN. Patients with known liver metastases who have an AST and ALT = 5 x ULN, • INR < 1.3 (INR < 3 in patients treated with anticoagulants); 6. Adequate renal function as shown by: serum creatinine = 1.5 x ULN; 7. Fasting serum cholesterol = 300 mg/dL OR = 7.75 mmol/L AND fasting triglycerides = 2.5 x ULN; 8. Written informed consent obtained before any trial related activity and according to local guidelines.
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma are not eligible; 2. Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to enrollment; 3. Hepatic artery embolization within the last 2 months or cryoablation or radiofrequency ablation of hepatic metastasis within 2 months of enrollment; 4. Prior therapy with mTOR inhibitors (for example sirolimus, temsirolimus, everolimus); 5. Patients with a known hypersensitivity to everolimus or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients; 6. Patients receiving chronic treatment with immunosuppressives; 7. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN; 8. Patients who have any severe and/or uncontrolled medical conditions such as: • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia, • active or uncontrolled severe infection, • Patients with a history of invasive fungal infections, • severe hepatic impairment (Child-Pugh class C), • severely impaired lung function; 9. Active bleeding diathesis; 10. Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required; 11. 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 = 3 years; 12. Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry. Note: Patients must have recovered from the acute effects of surgery prior to enrollment; 13. Female patients who are pregnant or nursing (lactating);14. Adults of reproductive potential who are not using effective birth control methods. Adequate contraceptives must be used throughout the trial and for 8 weeks after last study drug administration in female patients. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first administration of study drug; 15. Patients unwilling to or unable to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate additional safety of everolimus in patients with advanced neuroendocrine tumors of gastrointestinal, lung or pancreatic origin.;Secondary Objective: - To evaluate investigator-assessed best overall response in patients with advanced NETs of gastrointestinal, lung or pancreatic origin treated with everolimus; - To estimate investigator-assessed progression free survival (PFS); - To provide expanded access to everolimus in patients with advanced NETs of gastrointestinal, lung or pancreatic origin; - To assess disease related symptoms and changes in health related quality of life (HRQoL) over time in advanced neuroendocrine patients treated with everolimus.;Primary end point(s): To evaluate the safety of everolimus: grade 3 or 4 adverse events, serious adverse events, laboratory abnormalities of CTC grade 3 or 4.;Timepoint(s) of evaluation of this end point: 15 months or until disease progression, unacceptable toxicity, death, discontinuation from the study for any other reason.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - To evaluate investigator-assessed best overall response in patients with advanced NETs of gastrointestinal, lung or pancreatic origin treated with everolimus; - To estimate investigator-assessed progression free survival (PFS); - To provide expanded access to everolimus in patients with advanced NETs of gastrointestinal, lung or pancreatic origin; - To assess disease related symptoms and changes in health related quality of life (HRQoL) over time in advanced neuroendocrine patients treated with everolimus.;Timepoint(s) of evaluation of this end point: 15 months or until disease progression, unacceptable toxicity, death, discontinuation from the study for any other reason.