Cancer
Conditions
Brief summary
The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients. Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.
Detailed description
All patients receive background treatment with docetaxel.
Interventions
Intravenous route
DRUGplacebo
Intravenous route
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid malignancy, documented by pathologic report, for which treatment with single-agent docetaxel (administered every 3 weeks, at dose \<75 mg/m2)is planned. * Written informed consent
Exclusion criteria
* Patient has received more than 2 prior lines of cytotoxic-containing chemotherapy * 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 \>480 msec on screening ECG The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECG parameters (QTcF interval) | Cycle 1 and Cycle 3 |
Secondary
| Measure | Time frame |
|---|---|
| Other ECG parameters | Cycle 1 and Cycle 3 |
| Clinical safety (adverse events, serious adverse events) | maximum of 15 cycles |
| Pharmacokinetic parameters | Cycle 1 and Cycle 3 |
Countries
Belgium, Denmark, Germany, Italy, Romania, Turkey (Türkiye), United States
Outcome results
None listed