Neoplasm MalignantPhase 1NCT01148615
A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
A Phase 1 study testing Aflibercept (AVE0005) and Docetaxel (XRP6976) in people with Neoplasm Malignant, run by Sanofi at 1 site in China.
Trial summary
Primary Objective: To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- Aflibercept (AVE0005) and Docetaxel (XRP6976)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Dec 2011
- 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
- Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.
Who cannot join
- Squamous histology/cytology lung cancer
- Need for a major surgical procedure or radiation therapy during the study
- Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
- Cumulative radiation therapy to >25% of the total bone marrow
- History of brain metastases
- Eastern Cooperative Oncology Group(ECOG)>1
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- Prior docetaxel treatment but have not been appropriate for safety reasons
- Inadequate organ and bone marrow function
- Uncontrolled hypertension
- Evidence of clinically significant bleeding diathesis or underlying coagulopathy
- 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
1 site in 1 country.
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 Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies
Primary Objective:
- To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.
Read more
Secondary Objectives:
- To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel
- To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination
- To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease
- To evaluate the immunogenicity of IV aflibercept
- To measure endogenous free Vascular Endothelial Growth Factor (VEGF)
Read the detailed description
The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.
- Conditions
- Neoplasm Malignant
- Being tested
- Aflibercept (AVE0005), Docetaxel (XRP6976)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (AVE0005)Drug
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Docetaxel (XRP6976)Drug
Pharmaceutical form: solution for infusion
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept/ docetaxel | Experimental | Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel.
Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks Receives: Drug: Aflibercept (AVE0005); Drug: Docetaxel (XRP6976) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Measured: 3 weeks (cycle 1)
Secondary outcomes (6)
Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities
Measured: Up to 30 days after last administration within a maximum follow up of 18 months
Pharmacokinetic parameters of aflibercept
Measured: up to last aflibercept administration +90 days
Pharmacokinetic parameters of docetaxel
Measured: cycle 1
Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: up to a maximum follow-up of 18 months
Immunogenicity of Aflibercept
Measured: up to last aflibercept administration+90 days
Endogenous free VEGF
Measured: up to last aflibercept administration+30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionDec 2011
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 Neoplasm MalignantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01148615
- Sponsor's protocol ID
- TCD11382
- Other IDs
- U1111-1116-5774
- Status last verified
- Jan 2012
- First submitted
- 21 Jun 2010
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang Y, Zou BY, Zhao LP, Zhao HY, Zhao YY, Xue C, Zhang JW, Xu F, Chen LK, Liu JL, Hu ZH, Wu X, Zhang J, Ma YX, Wei CL, Ma Y, Zhang L. Phase I dose-escalation study of aflibercept plus docetaxel in nasopharyngeal carcinoma and other solid tumors. Future Oncol. 2014 Dec;10(16):2579-91. doi: 10.2217/fon.14.206.
PubMed 25531046
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. 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 Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01148615
- Acronym / sponsor ID
- TCD11382
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jun 2010 (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.
Primary Objective:
- To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.
Secondary Objectives:
- To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel
- To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination
- To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease
- To evaluate the immunogenicity of IV aflibercept
- To measure endogenous free Vascular Endothelial Growth Factor (VEGF)
Detailed description
The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept/ docetaxel | Experimental | Drug: Aflibercept (AVE0005), Drug: Docetaxel (XRP6976)Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel. Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.
Key exclusion criteria (11 listed)
- Squamous histology/cytology lung cancer
- Need for a major surgical procedure or radiation therapy during the study
- Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
- Cumulative radiation therapy to >25% of the total bone marrow
- 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)Pharmaceutical form: solution for infusion Route of administration: intravenous | Drug | Aflibercept/ docetaxel |
| Docetaxel (XRP6976)Pharmaceutical form: solution for infusion Route of administration: intravenous | Drug | Aflibercept/ docetaxel |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: 3 weeks (cycle 1)
6 secondary outcomes
Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities
Time frame: Up to 30 days after last administration within a maximum follow up of 18 months
Pharmacokinetic parameters of aflibercept
Time frame: up to last aflibercept administration +90 days
Pharmacokinetic parameters of docetaxel
Time frame: cycle 1
Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: up to a maximum follow-up of 18 months
Immunogenicity of Aflibercept
Time frame: up to last aflibercept administration+90 days
Endogenous free VEGF
Time frame: up to last aflibercept administration+30 days
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 13 Jan 2012.
- Derived from this study: PubMed 25531046Huang Y, Zou BY, Zhao LP, Zhao HY, Zhao YY, Xue C, Zhang JW, Xu F, Chen LK, Liu JL, Hu ZH, Wu X, Zhang J, Ma YX, Wei CL, Ma Y, Zhang L. Phase I dose-escalation study of aflibercept plus docetaxel in nasopharyngeal carcinoma and other solid tumors. Future Oncol. 2014 Dec;10(16):2579-91. doi: 10.2217/fon.14.206.
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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
1 site 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 (XRP6976) in people with Neoplasm Malignant, run by Sanofi at 1 site in China.
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 1 inclusion and 11 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 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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) (time frame: 3 weeks (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 NCT01148615, 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 13 Jan 2012.