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Ovarian NeoplasmsPhase 2NCT00396591

AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

A Phase 2 study testing Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in people with Ovarian Neoplasms, run by Sanofi at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
3 sitesin 3 countries
Study dates
Oct 2006to Nov 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
  • Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
  • Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.

Who cannot join

  • Peritoneovenous or other type of shunt that was placed for the management of ascites
  • Prior treatment with a VEGF or VEGF receptor inhibitor
  • Uncontrolled hypertension
  • The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

United States1 site

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey, 08807

Other trials in United States

Italy1 site

  • Sanofi-Aventis Administrative Office

    Milan

Other trials in Italy

Sweden1 site

  • Sanofi-Aventis Administrative Office

    Bromma

Other trials in Sweden

About this study

Official title: A Multicenter, Open-label, Single-arm Study of the Efficacy and Safety of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.

The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

Read the detailed description

The study consisted of:

  • A 30-day screening phase prior to Day 1
  • Day 1 registration and pre-treatment paracentesis
  • Aflibercept administration within 1-day of registration
  • Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
  • A 60-day post-treatment follow-up phase

During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:

  • Participant (or legal representative) chose to withdraw from treatment
  • The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
  • Participant had intercurrent illness that prevented further administration of investigational product (IP)
  • Participant had more than 2 IP dose reductions
  • Participant had unacceptable adverse events (AEs)
  • Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
  • Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation
Being tested
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Keywords
Ovarian cancer, malignant ascites, angiogenesis, angiogenesis inhibition, VEGF-Trap fusion recombinant protein
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)Drug

    4.0 mg/kg administered intravenously (IV) once every 2 weeks

Study groups in NCT00396591
Study groupRoleWhat they receive
AfliberceptExperimentalParticipants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
Receives: Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Repeat Paracentesis Response (RPR)

    RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis).

    Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants * 100.

    Measured: up to 2 years post-registration

Secondary outcomes (6)

  1. Time to Repeat Paracentesis (TRP)

    TRP is the number of days between the date of registration and the date of the first postregistration paracentesis. Median TRP was estimated from Kaplan-Meier curves. For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.

    Measured: up to 6 months from registration

  2. 60-day Frequency of Paracentesis (FOP)

    FOP was the total number of paracenteses performed within the first 60 days postregistration. For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.

    Measured: up to 60 days post-registration

  3. Progression-free Survival (PFS) Time

    According to the Response Evaluation Criteria in Solid Tumors [RECIST], progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.

    PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.

    If participants were alive and progression-free at 6 months postregistration, they were censored for PFS.

    Measured: up to 6 months post-registration

  4. Overall Survival (OS) Time

    OS time was the time interval between the date of registration to the date of death from any cause. Median OS was estimated from Kaplan-Meier curves. Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.

    Measured: up to 6 months post-registration

  5. Number of Participants With a Positive Anti-drug Antibody Response

    Anti-drug antibodies in participant's serum were measured using 2 different methods

    • an Enzyme Linked Immunosorbent Assay (ELISA) in which the lower limit of detection (LLOD) was 238.4 ng/mL; and
    • an Electrochemiluminescence-based, Bridging Assay in which the validated LLOD was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.

    Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response.

    Measured: up to 60 days after the last dose of treatment

  6. Safety - Number of Participants With Adverse Events (AE)

    All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.

    Measured: up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00396591
Sponsor's protocol ID
ARD6772
Other IDs
EUDRACT: 2006-000604-16
Status last verified
Jul 2011
First submitted
6 Nov 2006
Last updated
10 Jan 2013
Data monitoring committee
No

Publications

  • Colombo N, Mangili G, Mammoliti S, Kalling M, Tholander B, Sternas L, Buzenet G, Chamberlain D. A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites. Gynecol Oncol. 2012 Apr;125(1):42-7. doi: 10.1016/j.ygyno.2011.11.021. Epub 2011 Nov 21.

    PubMed 22112608

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in people with Ovarian Neoplasms, run by Sanofi at 3 sites in 3 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 3 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Italy, Sweden. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With a Repeat Paracentesis Response (RPR) (time frame: up to 2 years post-registration). 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 NCT00396591, 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 10 Jan 2013.

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