Efficacy and Safety of RAD001 (Everolimus) in Patients Affected by Biliary Tract Cancer Progressing After Prior Chemotherapy: a Phase II I.T.M.O. Study - Everolimus in biliary tract cancer

• Conditions: Patients affected by biliary tract cancer progressing after prior chemotherapy; MedDRA version: 9.1Level: LLTClassification code 10055111Term: Biliary cancer metastatic

• Registration Number: EUCTR2008-007152-94-IT
• Lead Sponsor: I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 75 years - PS 0-2 (ECOG) - Life expectancy >= 12 weeks Neutrophyls count >= 2 x 109 /L and platelets count >=100 x 109/L. - Total bilirubin <= 1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and or ALAT (SGPT) <= 2 x UNL (<= five times the UNL for patients with liver metastasis), alkaline phosphatase <= 2.5 x UNL (unless bone metastasis are present in the absence of any liver disorders) - Creatinine < 140 mmol/L (1.6 mg/dL); if limit values, the creatinine clearance should be performed and should be >= 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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified