Clinical trial · Interventional
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients
A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
NCT00876044CI-TRIAL-00022021QUTIEcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aflibercept (AVE0005) | Drug | Aflibercept | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 4 mg/kg every 2 weeks
- interventionNames
- Drug: aflibercept (AVE0005)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- matching placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- ECG parameters (QTcF interval)
- timeFrame
- Cycle 1 and Cycle 3
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMaison-Blanche P, Vermorken JB, Goksel T, Machiels JP, Agarwala S, Rottey S, Daugaard G, Volovat C, Scheulen M, Sengelov L, Grecea D, Eniu A, Jager E, Meiri E, Cascinu S, Strumberg D, Demir G, Clemens M, Pinotti G, Nardi M, Guthrie T, Boelle E, Magherini E. A randomized, double-blind, placebo-controlled study to assess QTc interval prolongation of standard dose aflibercept in cancer patients treated with docetaxel. J Cardiovasc Pharmacol. 2013 Jun;61(6):495-504. doi: 10.1097/FJC.0b013e31828b73ff. PMID 23429593