A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients
NCT ID: NCT00545246
Last Updated: 2013-10-16
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
12 participants
INTERVENTIONAL
2007-10-31
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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aflibercept + docetaxel
aflibercept (AVE0005)
intravenous infusion
docetaxel
intravenous infusion
Interventions
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aflibercept (AVE0005)
intravenous infusion
docetaxel
intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0 or 1
* Adequate organ and bone marrow function
Exclusion Criteria
* 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
* 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.
20 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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Sanofi-Aventis Investigational Site Number 392002
Iruma-gun, , Japan
Sanofi-Aventis Investigational Site Number 392001
Sunto-Gun, , Japan
Countries
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References
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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.
Other Identifiers
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TCD10091
Identifier Type: -
Identifier Source: org_study_id