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Ovarian Cancer RecurrentPhase 2OPSALINNCT01332656

Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

A Phase 2 study testing Ombrabulin (AVE8062), Paclitaxel and Carboplatin in people with Ovarian Cancer Recurrent, run by Sanofi at 38 sites in 10 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

Primary Objective: To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer Recurrent
What is being tested?
Ombrabulin (AVE8062), Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
38 sitesin 10 countries
Study dates
May 2011to Jul 2014
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • At least 18 years of age.
  • Histological and/or cytological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma.
  • Completion of maximum one previous line of chemotherapy containing a platinum agent. Neoadjuvant/adjuvant treatment that include a surgical procedure will be considered as one line if platinum-based.
  • Documented sensitivity to a platinum based chemotherapy regimen. "Platinum-sensitivity" is defined by a relapse more than 6 months after last dose of platinum-based chemotherapy.
  • Measurable progressive disease: Measurable disease (as defined by RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >15 mm in short axis when measured by CT or MRI. In case of a single measurable lesion, this should not be previously irradiated.
  • ECOG performance status ≤2
  • Life expectancy more than 12 weeks

Who cannot join

  • History of uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
  • History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 years are allowed.
  • Participation in another clinical trial and any concurrent treatment with any investigational drug or anti-tumor therapy or radiotherapy within 21 days prior to randomization (or 28 days for those therapies with a schedule of administration every 4 weeks and except for nitrosoureas, mitomycin which may not be used up to 6 weeks prior to the first cycle provided that patients do not have residual signs of any toxicity). No wash-out is required for hormonotherapy which has to be discontinued before the first cycle.
  • Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results.
  • Pregnancy or breast-feeding. Positive serum or urine pregnancy test prior to randomization.
  • Patient with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment. Effective method of contraception should also be adapted to local regulations.
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  • Inadequate organ function including: neutrophils <1.5 x 10^9/L; platelets <100 x 10^9/L; creatinine ≥ 1.5 ULN. If creatinine ≥ ULN, the calculated creatinine clearance should be ≥ 60 ml/min (as per Cockcroft Formula). Total bilirubin not within normal limit and ALT/AST/AP >2.5 times the upper normal limits of the institutional norms. An increase of AP up to grade 2 would be accepted only if this increase is related to the presence of bone metastases. Bone specific isoenzyme AP should be evaluated.
  • Urine protein-creatinin ratio (UPCR) >1 (urinanalysis on morning spot urine) or proteinuria >500 mg/24h
  • Pre-existing peripheral neuropathy > grade 1 according to the NCI CTCAE V.4.03
  • Pre-existing hearing impairment > grade 1
  • Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound/excipients of the study drug combination
  • Discontinuation of previous treatment with paclitaxel and/or carboplatin for toxicity reason
  • Other serious illness or medical conditions such as (but not restricted):
  • Active infection
  • Superior vena cava syndrome
  • Pericardial effusion requiring intervention (drainage)
  • Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thrombo-embolism within the past 6 months still requiring anticoagulants.
  • Cardiac Troponin at levels that exceed the normal ranges values defined by the laboratory
  • Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension.
  • Patient with LVEF value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography
  • 12-lead ECG:
  • Infarction Q-wave,
  • ST segment depression or elevation ≥1 mm in at least 2 contiguous leads
  • QT/QTc-Time > 450ms
  • 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

38 sites in 10 countries.

38 sites in 10 countries

United States5 sites

  • Investigational Site Number 840009

    Atlanta, Georgia, 30342

  • Investigational Site Number 840002

    Boston, Massachusetts, 02114

  • Investigational Site Number 840007

    Burbank, California, 91505

  • Investigational Site Number 840202

    Fort Meyers, Florida, 33919

  • Investigational Site Number 840001

    New Haven, Connecticut, 06510

Other trials in United States

France5 sites

  • Investigational Site Number 250006

    Bordeaux, 33076

  • Investigational Site Number 250004

    Caen, 14076

  • Investigational Site Number 250001

    Lyon, 69373

  • Investigational Site Number 250002

    Paris, 75181

  • Investigational Site Number 250003

    Villejuif, 94805

Other trials in France

Poland5 sites

  • Investigational Site Number 616002

    Krakow, 31-115

  • Investigational Site Number 616004

    Poznan, 60-569

  • Investigational Site Number 616003

    Rybnik, 44-200

  • Investigational Site Number 616005

    Warsaw, 02-061

  • Investigational Site Number 616001

    Warsaw, 02-781

Other trials in Poland

Belgium4 sites

  • Investigational Site Number 056002

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056005

    Kortrijk, 8500

  • Investigational Site Number 056001

    Leuven, 3000

  • Investigational Site Number 056003

    Namur, 5000

Other trials in Belgium

Czechia4 sites

  • Investigational Site Number 203003

    Nový Jičín, 74101

  • Investigational Site Number 203002

    Olomouc, 77520

  • Investigational Site Number 203001

    Prague, 12808

  • Investigational Site Number 203004

    Zlín, 76275

Other trials in Czechia

Russia4 sites

  • Investigational Site Number 643002

    Moscow, 115478

  • Investigational Site Number 643003

    Moscow, 115478

  • Investigational Site Number 643001

    Moscow, 129128

  • Investigational Site Number 643004

    Saint Petersburg, 194291

Other trials in Russia

Ukraine4 sites

  • Investigational Site Number 804003

    Dnipropetrovsk, 49102

  • Investigational Site Number 804005

    Donetsk, 83092

  • Investigational Site Number 804004

    Kharkiv, 61070

  • Investigational Site Number 804002

    Lviv, 70031

Other trials in Ukraine

Italy3 sites

  • Investigational Site Number 380004

    Genova, 16132

  • Investigational Site Number 380003

    Milan, 20141

  • Investigational Site Number 380001

    Roma, 00168

Other trials in Italy

Spain3 sites

  • Investigational Site Number 724002

    Barcelona, 08035

  • Investigational Site Number 724003

    Madrid, 28040

  • Investigational Site Number 724001

    Madrid, 28046

Other trials in Spain

Germany1 site

  • Investigational Site Number 276001

    München, 81737

Other trials in Germany

About this study

Official title: A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

Primary Objective:

  • To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.

Secondary Objectives:

  • To compare the overall survival (OS) between the 2 treatment arms
  • To compare the objective response rate (RR) between the 2 treatment arms
Read the detailed description

Treatment will continue until disease progression or unacceptable toxicity or consent withdrawal. A minimum of 6 cycles of the combined therapies should be administered, unless progression occurs before or safety reasons cause the discontinuation of one or two drugs of the combination therapies. In case of no progression, it will be investigator's decision to continue or not the study treatment after 6 cycles according to his clinical practice.

Being tested
Ombrabulin (AVE8062), Placebo, Paclitaxel, Carboplatin

What participants receive

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

  • Ombrabulin (AVE8062)Drug

    Pharmaceutical form:solution

    Route of administration: intravenous

  • PlaceboDrug

    Pharmaceutical form:solution

    Route of administration: intravenous

  • PaclitaxelDrug

    Pharmaceutical form:solution

    Route of administration: intravenous

  • CarboplatinDrug

    Pharmaceutical form:solution

    Route of administration: intravenous

Study groups in NCT01332656
Study groupRoleWhat they receive
Arm AExperimentalOmbrabulin, Paclitaxel and Carboplatin
Receives: Drug: Ombrabulin (AVE8062); Drug: Paclitaxel; Drug: Carboplatin
Arm BPlacebo comparatorPlacebo, Paclitaxel and Carboplatin
Receives: Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Progression Free Survival (PFS)

    Measured: approximately 24 months

Secondary outcomes (2)

  1. Overall Survival (OS)

    Measured: approximately 24 months

  2. Objective Response Rate (RR)

    Measured: approximately 24 months

Timeline

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

  1. First posted11 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJul 2014
  4. Study completionJul 2014

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01332656
Sponsor's protocol ID
EFC10260
Other IDs
2010-024631-16, U1111-1118-5437
Acronym
OPSALIN
Status last verified
Nov 2015
First submitted
7 Apr 2011
Last updated
21 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ombrabulin (AVE8062), Paclitaxel and Carboplatin in people with Ovarian Cancer Recurrent, run by Sanofi at 38 sites in 10 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 8 inclusion and 25 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, France, Poland, Belgium, Czechia and 5 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 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?

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?

Progression Free Survival (PFS) (time frame: approximately 24 months). 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 NCT01332656.

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 21 Dec 2015.

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