NeoplasmsPhase 1NCT00719524
AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor
A Phase 1 study testing OMBRABULIN (AVE8062) in people with Neoplasms, run by Sanofi at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- OMBRABULIN (AVE8062)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2008to Feb 2013
- 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
- Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
Who cannot join
- Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
- Absence of histologically or cytologically proven cancer at the first diagnosis.
- Negative serum/urinary pregnancy test
- Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment
- 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
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.
- Conditions
- Neoplasms
- Being tested
- OMBRABULIN (AVE8062)
- Keywords
- Neoplasms, Antineoplastic Combined Chemotherapy Protocol
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMBRABULIN (AVE8062)Drug
Dose escalation study with combination chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: OMBRABULIN (AVE8062) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose of the combination based on Dose Limiting Toxicities observed
Measured: Cycle 1
Secondary outcomes (3)
Overall safety profile
Measured: Treatment period
Pharmacokinetic profile
Measured: Cycle 1
Anti-tumor activity of the combination
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2013
- Study completionFeb 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 NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 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
- NCT00719524
- Sponsor's protocol ID
- TCD10620
- Other IDs
- EudraCT: 2007-006676-11
- Status last verified
- Mar 2013
- First submitted
- 17 Jul 2008
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6.
PubMed 24898305
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT00719524
- Acronym / sponsor ID
- TCD10620
- Conditions
- Neoplasms
- Keywords
- Neoplasms, Antineoplastic Combined Chemotherapy Protocol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Jul 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 purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OMBRABULIN (AVE8062) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
Key exclusion criteria (5 listed)
- Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
- Absence of histologically or cytologically proven cancer at the first diagnosis.
- Negative serum/urinary pregnancy test
- Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment
- 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)Dose escalation study with combination chemotherapy | Drug | 1 |
Primary outcome
Recommended dose of the combination based on Dose Limiting Toxicities observed
Time frame: Cycle 1
3 secondary outcomes
Overall safety profile
Time frame: Treatment period
Pharmacokinetic profile
Time frame: Cycle 1
Anti-tumor activity of the combination
Time frame: Every 2 cycles
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 11 Mar 2013.
- Derived from this study: PubMed 24898305Bahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6.
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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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMBRABULIN (AVE8062) in people with 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 2 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 11 Mar 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 France, Italy, Switzerland. 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 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?
Recommended dose of the combination based on Dose Limiting Toxicities observed (time frame: Cycle 1). 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 NCT00719524, 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 11 Mar 2013.