A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients (QUTIE)
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00876044
First received: April 3, 2009
Last updated: December 13, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: aflibercept (AVE0005) Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- ECG parameters (QTcF interval) [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Other ECG parameters [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]
- Clinical safety (adverse events, serious adverse events) [ Time Frame: maximum of 15 cycles ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters [ Time Frame: Cycle 1 and Cycle 3 ] [ Designated as safety issue: No ]
| Enrollment: | 88 |
| Study Start Date: | April 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
4 mg/kg every 2 weeks
|
Drug: aflibercept (AVE0005)
Intravenous route
|
|
Placebo Comparator: 2
matching placebo
|
Drug: placebo
Intravenous route
|
Detailed Description:
All patients receive background treatment with docetaxel.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876044
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Horsholm, Denmark | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| Italy | |
| Sanofi-Aventis Administrative Office | |
| Milano, Italy | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Turkey | |
| Sanofi-Aventis Administrative Office | |
| Istanbul, Turkey | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00876044 History of Changes |
| Other Study ID Numbers: | TES10897, EudraCT:2008-006796-80 |
| Study First Received: | April 3, 2009 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on June 18, 2013