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Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer

NCT ID: NCT00921661

Last Updated: 2012-11-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-06-30

Brief Summary

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The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer.

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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Colorectal Neoplasms Neoplasm Metastasis

Keywords

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oxaliplatin 5-FU Folinic Acid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVE0005 (aflibercept)

Group Type EXPERIMENTAL

AVE0005 (aflibercept)

Intervention Type DRUG

IV infusion

Interventions

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AVE0005 (aflibercept)

IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically or cytologically proven malignant tumor of the colon or rectum which is metastatic and inoperable.
* Patients must have received at least one prior line of treatment with any standard of care, who have failed the treatment, or who have not been eligible for standard of care for safety reasons.

Exclusion Criteria

* Treatment with chemotherapy, hormone therapy, radiotherapy, surgery, blood products, or any investigational agent within 28 days.
* ECOG Performance Status\>1
* Anticipated need for a major surgical procedure or radiation therapy during the study.
* Uncontrolled malignant ascites.
* History of brain metastases, spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
* Pregnant or breast-feeding women.
* Uncontrolled hypertension
* Patients who have previously been treated with aflibercept
* History of abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days.
* History of hypersensitivity to any recombinant proteins, irinotecan, fluoropyrimidine or isovorin.
* Known dihydropyrimidine dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Yoshino T, Yamazaki K, Yamaguchi K, Doi T, Boku N, Machida N, Onozawa Y, Asayama M, Fujino T, Ohtsu A. A phase I study of intravenous aflibercept with FOLFIRI in Japanese patients with previously treated metastatic colorectal cancer. Invest New Drugs. 2013 Aug;31(4):910-7. doi: 10.1007/s10637-012-9895-6. Epub 2012 Nov 20.

Reference Type DERIVED
PMID: 23179335 (View on PubMed)

Other Identifiers

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TCD10794

Identifier Type: -

Identifier Source: org_study_id