A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies
NCT ID: NCT01930552
Last Updated: 2015-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2013-09-30
2014-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
Aflibercept AVE0005
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Leucovorin
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Irinotecan
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
5-Fluorouracil
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Interventions
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Aflibercept AVE0005
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Leucovorin
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Irinotecan
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
5-Fluorouracil
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 156002
Beijing, , China
Investigational Site Number 156001
Guangzhou, , China
Countries
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Other Identifiers
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U1111-1115-7286
Identifier Type: OTHER
Identifier Source: secondary_id
TCD11470
Identifier Type: -
Identifier Source: org_study_id
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