To determine whether treatment with RAD001 10 mg/d plus best supportive care prolongs the progression free survival (PFS) compared to treatment with Placebo plus best supportive care in patients with advanced pancreatic neuroendocrine tumor.
ID
Source
Brief title
Condition
- Neoplastic and ectopic endocrinopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression Free Survival
Secondary outcome
Objective Response Rate and Response Duration, Overall Survival, safety and
tolerability of RAD001, pharmacokinetics of RAD001, tumormarkers, angiogenesis
biomarkers, immunohistochemical and genetic mTOR pathway characterization on
pre-treatment tumor material.
Background summary
The treatment options for unresectable or metastatic panreatic NET patients are
limited.
In this cancer, the mTOR signal transduction pathway is activated in response
to signaling by the insulin-like growth factor 1 (IGF-1). Interruption of this
pathway by RAD001 could slow douwn tumor growth or could diminish tumor size.
Earlier phase 1 and 2, and ongoing phase 2 studies show promising results.
Study objective
To determine whether treatment with RAD001 10 mg/d plus best supportive care
prolongs the progression free survival (PFS) compared to treatment with Placebo
plus best supportive care in patients with advanced pancreatic neuroendocrine
tumor.
Study design
Multicenter, randomized, placebo controlled, double blind, phase 3 study with
RAD001 in patients with advanced pancreatic NET; best supportive care as
background treatment.
Intervention
RAD001 or placebo.
Study burden and risks
Toxicity of RAD001.
Radiation exposure of CT-scans.
Raapopseweg 1
6824 DP Arnhem
NL
Raapopseweg 1
6824 DP Arnhem
NL
Listed location countries
Age
Inclusion criteria
- Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
- Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Patients must have radiological documentation of progression of disease within 12 months prior to randomization. If patient received anti-tumor therapy during the past 12 months, he/she must have radiological documentation of progression of disease while on or after receiving the therapy
- Measurable disease per RECIST criteria.
- Adequate bone marrow, liver and renal function.
- Fasting serum cholesterol * 300 mg/dL OR * 7.75 mmol/L AND fasting triglycerides * 2.5 x ULN.
Exclusion criteria
- Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma.
- Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to
randomization.
- Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment.
- Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- Uncontrolled diabetes mellitus.
- Patients who have any severe and/or uncontrolled medical conditions.
- Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent.
- Patients with a known history of HIV seropositivity.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006819-75-NL |
| CCMO | NL18207.042.07 |