Neoplasm MalignantPhase 1NCT01930552
A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies
A Phase 1 study testing Aflibercept AVE0005, Leucovorin and Irinotecan in people with Neoplasm Malignant, run by Sanofi at 2 sites in China.
Trial summary
Primary Objective: To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 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, Leucovorin and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2013to Dec 2014
- 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 is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate
Who cannot join
- Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
- Eastern Cooperative Oncology Group (ECOG) >1
- Need for a major surgical procedure or radiation therapy during the study
- Diagnosis of squamous-cell lung cancer
- Cumulative radiation therapy to > 25% of the total bone marrow
- History of brain metastases
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- Inadequate organ and bone marrow function
- Uncontrolled hypertension
- Evidence of clinically significant bleeding diathesis or underlying coagulopathy
- Prior FOLFIRI treatment but have not been appropriate for safety reasons
- Patients with known Gilbert's syndrome
- 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
2 sites in 1 country.
China2 sites
Investigational Site Number 156002
Beijing, 100071
Investigational Site Number 156001
Guangzhou, 510060
About this study
Official title: A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies
Primary Objective:
To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.
Secondary Objectives:
- To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).
- To evaluate the immunogenicity of IV aflibercept.
Read the detailed description
Total duration of the study per patient is in the range of 17 to 29 weeks.
This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
- Conditions
- Neoplasm Malignant
- Being tested
- Aflibercept AVE0005, Leucovorin, Irinotecan, 5-Fluorouracil
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept AVE0005Drug
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
LeucovorinDrug
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
IrinotecanDrug
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
5-FluorouracilDrug
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks Receives: Drug: Aflibercept AVE0005; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with standard safety assessments (adverse events and laboratory tests)
Measured: Up to last treatment + 30 days
Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
Measured: Up to last aflibercept administration + 90 days
Secondary outcomes (3)
Anti-tumor activity assessment - overall response rate
Measured: Up to 17 Weeks
Anti-tumor activity assessment - duration response
Measured: Up to 17 Weeks
Anti-aflibercept antibody detection
Measured: Up to last aflibercept administration + 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- 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
- NCT01930552
- Sponsor's protocol ID
- TCD11470
- Other IDs
- U1111-1115-7286
- Status last verified
- Jan 2015
- First submitted
- 14 Aug 2013
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01930552
- Acronym / sponsor ID
- TCD11470
- 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
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Aug 2013 (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 assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.
Secondary Objectives:
- To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).
- To evaluate the immunogenicity of IV aflibercept.
Detailed description
Total duration of the study per patient is in the range of 17 to 29 weeks.
This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Aflibercept AVE0005, Drug: Leucovorin, Drug: Irinotecan, Drug: 5-Fluorouracilaflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 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 is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate
Key exclusion criteria (12 listed)
- Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
- Eastern Cooperative Oncology Group (ECOG) >1
- Need for a major surgical procedure or radiation therapy during the study
- Diagnosis of squamous-cell lung cancer
- Cumulative radiation therapy to > 25% of the total bone marrow
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 AVE0005Pharmaceutical form:Solution for infusion Route of administration: Intravenous | Drug | Cohort 1 |
| LeucovorinPharmaceutical form:Solution for infusion Route of administration: Intravenous | Drug | Cohort 1 |
| IrinotecanPharmaceutical form:Solution for infusion Route of administration: Intravenous | Drug | Cohort 1 |
| 5-FluorouracilPharmaceutical form:Solution for infusion Route of administration: Intravenous | Drug | Cohort 1 |
Primary outcome
Number of patients with standard safety assessments (adverse events and laboratory tests)
Time frame: Up to last treatment + 30 days
Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
Time frame: Up to last aflibercept administration + 90 days
3 secondary outcomes
Anti-tumor activity assessment - overall response rate
Time frame: Up to 17 Weeks
Anti-tumor activity assessment - duration response
Time frame: Up to 17 Weeks
Anti-aflibercept antibody detection
Time frame: Up to last aflibercept administration + 90 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 7 Jan 2015.
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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, Leucovorin and Irinotecan in people with Neoplasm Malignant, run by Sanofi at 2 sites 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 12 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 7 Jan 2015. 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 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?
Number of patients with standard safety assessments (adverse events and laboratory tests) (time frame: Up to last treatment + 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2015.