Colorectal Neoplasms MedDRA version: 16.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Aflibercept
Product Code: AVE0005
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Current Sponsor code: AVE0005
Other
Sponsors
Sanofi aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically proven adenocarcinoma of the colon or rectum Metastatic disease Eastern Cooperative Oncology Group performance status 0-1 One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy must be an oxaliplatin containing regimen. Patients must have progressed during or after the oxaliplatin based chemotherapy. Patients relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy are eligible. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: Prior therapy with irinotecan Inadequate bone marrow, liver and renal function: neutrophils 1.5 x upper normal limit (ULN), transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN. Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major surgery (or until the surgical wound is fully healed). Treatment with any investigational drug within the prior 30 days. Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. Prior malignancy (other than colorectal) including prior malignancy from which the patient has been disease free for 1 on morning spot urinalysis or proteinuria > 500 mg/24-h. Uncontrolled hypertension within 3 months prior to study inclusion. Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range INR within the 4 weeks prior to study inclusion. Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound. Pregnant or breast-feeding women. Patients with reproductive potential who do not agree to use an accepted effective method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide mCRC patients (similar to the patients evaluated in the VELOUR phase III trial) and Investigators with access to aflibercept, prior to its marketing authorisation and/or commercial availability and to document the aflibercept overall safety in this patient population. ;Secondary Objective: To document the Health-Related Quality of Life (HRQL) of aflibercept in this patient population. ;Primary end point(s): - Number of participants reporting adverse events - Number of participants reporting laboratory abnormalities;Timepoint(s) of evaluation of this end point: Up to 30 days after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Health-Related Quality of Life (HRQL) assessed by using changes from baseline in scores derived from the 3 HRQL questionnaires;Timepoint(s) of evaluation of this end point: Every 4 weeks | — |
Countries
Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, Germany, Hungary, India, Ireland, Israel, Italy, Netherlands, Norway, Slovenia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactBrigitte De Witte
Sanofi Belgium
Outcome results
None listed