metastatic colorectal adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10051925 Term: Intestinal adenocarcinoma
Conditions
Interventions
Product Name: EVEROLIMUS
Product Code: RAD001C
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351-69-6
Current Sponsor code: RAD001C
Concentration unit: mg milligram(s)
Con
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 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
Exclusion criteria
Exclusion criteria: - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess disease control rate (DCR) and then objective response rate (ORR) as a measure of the anti-tumor activity of RAD001.;Secondary Objective: To assess DCR and ORR as a measure of the antitumor activity of RAD001 according to PI 3-kinase mutational status and PTEN (protein)expression. To assess progression-free survival and overall survival among all patients on RAD001, and according to PI 3-kinase mutational status and PTEN (protein) expression. To describe the safety profile of RAD001. To explore other biomarkers that may be predictive of clinical benefit on 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 ( + o -1 week), according to RECIST. The denominator is the number of evaluable patients, defined as treated patients with an overall objective response at week 8 ( + o -1 week) Objective response rate (ORR), defined as the proportion of patients with a best overall response of CR or PR, as per RECIST. 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