Cancer MedDRA version: 11.0 Level: LLT Classification code 10007050 Term:
Conditions
Interventions
Product Name: Aflibercept / VEGF Trap
Product Code: AVE0005
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: AVE0005
Other descriptive name: VEGF Trap - Aflibercept
Con
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient has a solid malignancy, documented by pathologic report, for which treatment with single-agent docetaxel (administered every 3 weeks, at dose =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Related to study metho QT interval assessment - Prior history of torsades de pointe, or congenital long QT syndrome - Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter - QTcF interval >480 msec on screening ECG - Significant hypokalemia at screening (K+ 1 (NCI CTCAE v3.0) from prior therapy (except alopecia and those listed in exclusion criteria) at time of rando - Prior treatment with anthracyclines at a cumulative dose putting patient at significant risk of cardiac failure - Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >25% of the total bone marrow - Planned or anticipation of treatment with surgery, radiation therapy or any chemotherapy (including targeted therapy) other than study treatment - History of brain metastases, uncontrolled spinal cord compression, carcinomatosis meningitits, or new evidence of brain or leptomeningeal disease Other patient characteristics or medical history - Age 1 - Participation in another clinical trial or concurrent treatment with any investigational agent within 28 days prior to rando - History of another neoplasm. Adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 yrs are allowed. - Any of the following events within 3 months prior to rando: treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. - Any of the following events within the 6 months prior to rando: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack. - Occurrence of deep vein thrombosis within 4 weeks prior to rando. - Acquired immunodeficiency syndrome or known human immunodeficiency virus disease requiring antiretroviral treatment - Any condition or situation which would make patient unlikely to complete at least 3 cycles of double-blind treatment, or which would interfere with interpretation of study results - Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to rando. - Patient with reproductive potential who does not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of effective method of contraception will be based on the investigators’ judgment. • Related to docetaxel - History of hypersensitivity to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect on QTcF interval (QTc Fridericia) of aflibercept versus placebo, in cancer patients.;Secondary Objective: To assess the effects of aflibercept versus placebo on heart rate (HR), QT, QTcB (Bazett’s correction), and QTcN (population specific correction formula) intervals. To assess the overall clinical safety of the two treatment arms. To assess the PK profile of aflibercept (administered every 3 weeks) over 3 cycles. ;Primary end point(s): QTcF, derived from manually read QT interval. | — |
Countries
Denmark, Germany, Italy
Outcome results
None listed