A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients (QUTIE)

Sanofi

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: aflibercept (AVE0005); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876044

EudraCT:2008-006796-80

TES10897

Details and patient eligibility

About

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.

Full description

All patients receive background treatment with docetaxel.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

88 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

4 mg/kg every 2 weeks

Treatment:

Drug: aflibercept (AVE0005)

2

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: placebo