A single arm, multicenter phase II study of RAD001 in patients with metastatic colorectal adenocarcinoma whose cancer has progressed despite prior therapy with an anti-EGFR antibody (if appropriate), evacizumab, fluoropyrimidine, oxaliplatin, and irinotecan-based regimens - ND
- Conditions
- metastatic colorectal adenocarcinomaMedDRA version: 9.1Level: LLTClassification code 10051925Term: Intestinal adenocarcinoma
- Registration Number
- EUCTR2006-003255-20-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
Age >=18 years old. Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor. Patients must have obtainable tumor tissue for biomarker analysis; only the original surgical resection is acceptable. Tumor tissue must be identified and reviewed to make certain that there is adequate tumor tissue available for biomarker evaluations, but actual procurement is not mandatory prior to study entry. Patients with radiologically documented progressive disease by RECIST during prior treatment or within 6 months of their most recent dose of chemotherapeutic regimens containing a fluoropyrimidine or oxaliplatin or irinotecan or targeted agent. Patients must have previously received anti- EGFR antibody (if appropriate), bevacizumab, fluoropyrimidine, oxaliplatin and irinotecan-based treatments. Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI), or physical examination. Adequate bone marrow function as shown by: ANC >= 1.5 x 109/L, Platelets >= 100 x 109/L, Hb >9 g/dL. Adequate liver function (serum bilirubin <= 1.5 x ULN, ALT and AST <= 2.5x ULN); patients with known liver metastases, AST and ALT <= 5x ULN. Adequate renal function: serum creatinine <= 2 x ULN or 24-hour creatinine clearance >= 50cc/24 hour. Patients with a life expectancy >= 3 months. Patients with a WHO performance status of 0, 1, or 2.
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
- Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry. - Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients. - Chronic treatment with steroids or another immunosuppressive agent. - A known history of HIV seropositivity. - Patients with an active, bleeding diathesis. Patients may use enoxaparin. - Patients with untreated CNS metastases or neurologically unstable CNS metastases. - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction <= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5x ULN any active (acute or chronic) or uncontrolled infection/ disorders. nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study therapy liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis - Patients who have a history of another primary malignancy <= 3 years, with the exceptions of non-melanoma skin cancer and carcinoma in situ of uterine cervix. - Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Oral contraceptives are not acceptable. - Patients who are using other investigational agents or who had received investigational drugs <= 4 weeks prior to first study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method