NeoplasmsPhase 1NCT00545246
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients
A Phase 1 study testing aflibercept (AVE0005) and docetaxel in people with Neoplasms, run by Sanofi at 2 sites in Japan.
Trial summary
The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients. The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- aflibercept (AVE0005) and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2007to Jul 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed cancer patients without standard of care
- ECOG performance status 0 or 1
- Adequate organ and bone marrow function
Who cannot join
- Need for a major surgery or radiation therapy during the study
- History of hypersensitivity to docetaxel or polysorbate 80
- Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days
- Uncontrolled hypertension
- History of brain metastases
- Ascites requiring drainage
Show all 9Show fewer
- Pregnancy or breastfeeding
- Patients who have previously been treated with aflibercept.
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Sanofi-Aventis Investigational Site Number 392002
Iruma-gun
Sanofi-Aventis Investigational Site Number 392001
Sunto-Gun
About this study
Official title: A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies
The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.
The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aflibercept (AVE0005)Drug
intravenous infusion
docetaxelDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| aflibercept + docetaxel | Experimental | Not described Receives: Drug: aflibercept (AVE0005); Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Measured: first 3-week cycle
Secondary outcomes (3)
safety: physical examination, laboratory safety tests, adverse events
Measured: up to 60 days after last treatment
pharmacokinetic values
Measured: every 3-week cycle
objective response rate
Measured: every 3-week cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2012
- Study completionJul 2012
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
- 12 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
- NCT00545246
- Sponsor's protocol ID
- TCD10091
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2007
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sunakawa Y, Takahashi K, Kawaguchi O, Yamamoto N. Phase I study of aflibercept in combination with docetaxel in Japanese patients with advanced solid malignancies. Invest New Drugs. 2022 Oct;40(5):1032-1041. doi: 10.1007/s10637-022-01267-x. Epub 2022 Jun 30.
PubMed 35771301
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00545246
- Acronym / sponsor ID
- TCD10091
- Conditions
- Neoplasms
- Keywords
- VEGF Trap
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Oct 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Oct 2007 (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 determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.
The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aflibercept + docetaxel | Experimental | Drug: aflibercept (AVE0005), Drug: docetaxel |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed cancer patients without standard of care
- ECOG performance status 0 or 1
- Adequate organ and bone marrow function
Key exclusion criteria (9 listed)
- Need for a major surgery or radiation therapy during the study
- History of hypersensitivity to docetaxel or polysorbate 80
- Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days
- Uncontrolled hypertension
- History of brain metastases
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 infusion | Drug | aflibercept + docetaxel |
| docetaxelintravenous infusion | Drug | aflibercept + docetaxel |
Primary outcome
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Time frame: first 3-week cycle
3 secondary outcomes
safety: physical examination, laboratory safety tests, adverse events
Time frame: up to 60 days after last treatment
pharmacokinetic values
Time frame: every 3-week cycle
objective response rate
Time frame: every 3-week cycle
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 16 Oct 2013.
- Derived from this study: PubMed 35771301Sunakawa Y, Takahashi K, Kawaguchi O, Yamamoto N. Phase I study of aflibercept in combination with docetaxel in Japanese patients with advanced solid malignancies. Invest New Drugs. 2022 Oct;40(5):1032-1041. doi: 10.1007/s10637-022-01267-x. Epub 2022 Jun 30.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aflibercept (AVE0005) and docetaxel in people with Neoplasms, run by Sanofi at 2 sites in Japan.
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 9 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities (time frame: first 3-week cycle). 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 NCT00545246, 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 16 Oct 2013.