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

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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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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