SarcomaPhase 3NCT00699517
A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
A Phase 3 study testing OMBRABULIN (AVE8062) in people with Sarcoma, run by Sanofi at 45 sites in 10 countries.
Trial summary
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms The secondary objectives of the study are : To compare the overall survival in the 2 treatment arms To compare the objective response rate in the 2 treatment arms To assess the safety profile of AVE8062 (in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- OMBRABULIN (AVE8062)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- 45 sitesin 10 countries
- Study dates
- Jun 2008to Apr 2013
- Phase
- Phase 3
- 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
- Histologically proven soft tissue sarcoma
- Unresectable locoregional recurrent or metastatic soft tissue sarcoma
- Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy
Who cannot join
- Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
- Brain metastases and carcinomatous leptomeningitis
- Uncontrolled hypertension
- Known platinum hypersensitivity
- 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
45 sites in 10 countries.
45 sites in 10 countries
France11 sites
Investigational Site Number 250008
Bordeaux, 33076
Investigational Site Number 250002
Dijon, 21079
Investigational Site Number 250004
Lille, 59010
Investigational Site Number 250001
Lyon, 69437
Investigational Site Number 250010
Marseille, 13385
Investigational Site Number 250006
Montpellier, 34094
Investigational Site Number 250007
Nice, 06189
Investigational Site Number 250005
Rennes, 35000
Investigational Site Number 250003
Saint-Cloud, 92210
Investigational Site Number 250009
Saint-Herblain, 44800
Investigational Site Number 250012
Saint-Priest-en-Jarez, 42270
Brazil8 sites
Investigational Site Number 076007
Belo Horizonte, 30130-100
Investigational Site Number 076008
Goiânia, 74070-040
Investigational Site Number 076003
Ijuí, 98700 000
Investigational Site Number 076004
Jaú, 17210-120
Investigational Site Number 076006
Novo Hamburgo, 93511 970
Investigational Site Number 076002
Porto Alegre, 90020-090
Investigational Site Number 076005
Porto Alegre, 90035 003
Investigational Site Number 076009
Rio de Janeiro, 20230-130
United States6 sites
Investigational Site Number 840005
Maywood, Illinois, 60153
Investigational Site Number 840002
Newark, New Jersey, 07103
Investigational Site Number 840003
Orlando, Florida, 32806
Investigational Site Number 840007
Philadelphia, Pennsylvania
Investigational Site Number 840001
San Antonio, Texas, 78229
Investigational Site Number 840004
Santa Monica, California, 90403
Italy4 sites
Investigational Site Number 380001
Aviano, 33081
Investigational Site Number 380003
Milan, 20133
Investigational Site Number 380004
Milan, 20141
Investigational Site Number 380002
Rozzano, 20089
Belgium3 sites
Investigational Site Number 056001
Brussels, 1200
Investigational Site Number 056004
Haine-Saint-Paul, 7100
Investigational Site Number 056005
Liège, 4000
India3 sites
Investigational Site Number 356005
Bangalore, 560054
Investigational Site Number 356003
Hyderabad, 500033
Investigational Site Number 356004
New Delhi, 110076
Spain3 sites
Investigational Site Number 724004
Barcelona, 08025
Investigational Site Number 724001
Madrid, 28040
Investigational Site Number 724003
Pamplona, 31008
United Kingdom3 sites
Investigational Site Number 826001
Bebington, CH63 4JY
Investigational Site Number 826003
Bristol, BS2 8ED
Investigational Site Number 826002
Newcastle upon Tyne, NE4 6BE
Hungary2 sites
Investigational Site Number 348001
Budapest, 1134
Investigational Site Number 348002
Debrecen, 4032
Serbia2 sites
Investigational Site Number 891001
Belgrade, 11000
Investigational Site Number 891002
Kamenitz, 21204
About this study
Official title: A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms
The secondary objectives of the study are :
- To compare the overall survival in the 2 treatment arms
- To compare the objective response rate in the 2 treatment arms
- To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
- To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
- Conditions
- Sarcoma
- Being tested
- OMBRABULIN (AVE8062), Placebo
- Keywords
- tubulin modulator, endothelium, combretastatin, cisplatin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMBRABULIN (AVE8062)Drug
I.V. infusion followed by administration of cisplatin
PlaceboDrug
I.V. infusion followed by administration of cisplatin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: OMBRABULIN (AVE8062) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: until event or study cut-off date (Tumor assessment every 6 weeks)
Secondary outcomes (3)
Overall survival
Measured: until event or study cut-off date
Response rate
Measured: tumor assessment every 6 weeks
Safety profile
Measured: assessment every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2013
- Study completionApr 2013
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 SarcomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699517
- Sponsor's protocol ID
- EFC10145
- Other IDs
- EudraCT 2007-003592-39
- Status last verified
- Nov 2015
- First submitted
- 7 May 2008
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blay JY, Papai Z, Tolcher AW, Italiano A, Cupissol D, Lopez-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saada-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.
PubMed 25864104
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.
- ClinicalTrials.gov ID
- NCT00699517
- Acronym / sponsor ID
- EFC10145
- Conditions
- Sarcoma
- Keywords
- tubulin modulator, endothelium, combretastatin, cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Jun 2008 (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 the study is to compare the progression-free survival (PFS) in the 2 treatment arms
The secondary objectives of the study are :
- To compare the overall survival in the 2 treatment arms
- To compare the objective response rate in the 2 treatment arms
- To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
- To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
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: OMBRABULIN (AVE8062) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven soft tissue sarcoma
- Unresectable locoregional recurrent or metastatic soft tissue sarcoma
- Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy
Key exclusion criteria (5 listed)
- Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
- Brain metastases and carcinomatous leptomeningitis
- Uncontrolled hypertension
- Known platinum hypersensitivity
- 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 |
|---|---|---|
| OMBRABULIN (AVE8062)I.V. infusion followed by administration of cisplatin | Drug | 1 |
| PlaceboI.V. infusion followed by administration of cisplatin | Drug | 2 |
Primary outcome
Progression free survival
Time frame: until event or study cut-off date (Tumor assessment every 6 weeks)
3 secondary outcomes
Overall survival
Time frame: until event or study cut-off date
Response rate
Time frame: tumor assessment every 6 weeks
Safety profile
Time frame: assessment every 3 weeks
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 21 Dec 2015.
- Derived from this study: PubMed 25864104Blay JY, Papai Z, Tolcher AW, Italiano A, Cupissol D, Lopez-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saada-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.
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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
45 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OMBRABULIN (AVE8062) in people with Sarcoma, run by Sanofi at 45 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 3 inclusion and 5 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 45 sites in France, Brazil, United States, Italy, Belgium 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: until event or study cut-off date (Tumor assessment every 6 weeks)). 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 NCT00699517, 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 21 Dec 2015.