CancerPhase 1QUTIENCT00876044
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients
A Phase 1 study testing aflibercept (AVE0005) in people with Cancer, run by Sanofi at 7 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- aflibercept (AVE0005)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Apr 2009to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
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.
Read the detailed description
All patients receive background treatment with docetaxel.
- Conditions
- Cancer
- Being tested
- aflibercept (AVE0005), placebo
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aflibercept (AVE0005)Drug
Intravenous route
placeboDrug
Intravenous route
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4 mg/kg every 2 weeks Receives: Drug: aflibercept (AVE0005) |
| 2 | Placebo comparator | matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG parameters (QTcF interval)
Measured: Cycle 1 and Cycle 3
Secondary outcomes (3)
Other ECG parameters
Measured: Cycle 1 and Cycle 3
Clinical safety (adverse events, serious adverse events)
Measured: maximum of 15 cycles
Pharmacokinetic parameters
Measured: Cycle 1 and Cycle 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876044
- Sponsor's protocol ID
- TES10897
- Other IDs
- EudraCT:2008-006796-80
- Acronym
- QUTIE
- Status last verified
- May 2016
- First submitted
- 3 Apr 2009
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Maison-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.
PubMed 23429593
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel
- ClinicalTrials.gov ID
- NCT00876044
- Acronym / sponsor ID
- QUTIE / TES10897
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aflibercept (AVE0005)4 mg/kg every 2 weeks |
| 2 | Placebo comparator | Drug: placebomatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aflibercept (AVE0005)Intravenous route | Drug | 1 |
| placeboIntravenous route | Drug | 2 |
Primary outcome
ECG parameters (QTcF interval)
Time frame: Cycle 1 and Cycle 3
3 secondary outcomes
Other ECG parameters
Time frame: Cycle 1 and Cycle 3
Clinical safety (adverse events, serious adverse events)
Time frame: maximum of 15 cycles
Pharmacokinetic parameters
Time frame: Cycle 1 and Cycle 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Results publication: PubMed 23429593Maison-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aflibercept (AVE0005) in people with Cancer, run by Sanofi at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium, Denmark, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG parameters (QTcF interval) (time frame: Cycle 1 and Cycle 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.