Patients affected by biliary tract cancer progressing after prior chemotherapy MedDRA version: 9.1 Level: LLT Classification code 10055111 Term: Biliary cancer metastatic
Conditions
Interventions
Product Name: EVEROLIMUS
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically proven diagnosis of biliary tract carcinomas (BTC) - Locally advanced, metastatic, or recurrent biliary tract cancer who had received not more than one previous chemotherapy regimen for their metastatic disease. If adjuvant chemotherapy and/or radiotherapy has been done, it is not considered as one line - Not indication to surgery or radiotherapy for locally advanced disease - At least one measurable site of disease according to RECIST criteria - Age > 18 and = 12 weeks Neutrophyls count >= 2 x 109 /L and platelets count >=100 x 109/L. - Total bilirubin = 60 ml / min. - No previous chemotherapy, radiation therapy or major surgical procedures within 4 weeks before study entry - Written informed consent - Patients must be accessible for treatment and follow up. Patients registered in this trial must be treated and followed at the participating centers 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 who received VEGFi therapy within 4 weeks prior to study entry - Patients who received prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus) - Patients with known hypersensitivity to RAD001(everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients - Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. Inhaled and topical steroids are acceptable - Patients with a known history of HIV seropositivity - Patients with autoimmune hepatitis - Patients with an active, bleeding diathesis. Patients may use coumadin or heparin preparations - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: - Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia - History of significant neurological or psychiatric disorders including dementia or seizures - Active infections - Past or current history of neoplasm other than curatively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix - Presence of metastatic CNS involvement - Patients that are currently, or in the 30 days prior to study screening, receiving other investigational agents - Patients with malabsorption syndrome or any other disorder that would affect gastrointestinal absorption - Patients unwilling or unable to comply with the requisites of the protocol - Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the disease control rate (DCR) and objective response rate (ORR) as a measure of the antitumor effect of RAD001;Secondary Objective: To assess DCR and ORR as a measure of the antitumor effect of RAD001, according to mTOR expression in tumor cells as optional biomarker study. To assess progression-free survival (PFS) and overall survival (OS) among all patients on RAD001, and according to mTOR expression as optional biomarker study. To describe the safety profile of RAD001;Primary end point(s): Disease control rate (DCR), defined as the proportion of patients with CR (complete response), PR (partial response) or SD (stable disease) as overall objective response at the tumor assessment performed at 8 weeks, according to RECIST criteria. The denominator is the number of evaluable patients, defined as treated patients with an overall objective response at week 8 other than Unknown, or with progression or death from progressive disease before week 8. Objective response rate (ORR), defined as the proportion of patients with a best overall response of CR or PR, as per RECIST criteria. ORR will be estimated in the intention to treat (ITT) population, defined as all patients who received at least one dose of RAD001 | — |
Countries
Italy
Outcome results
None listed