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

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastasis

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

AVE0005 (aflibercept)

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring oxaliplatin, 5-FU, Folinic Acid

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVE0005 (aflibercept)

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT) combination with FOLFIRI

Secondary Outcome Measures

physical examination, laboratory safety tests, adverse events

Pharmacokinetics

Tumor burden, endogenous free VEGF

Immunogenicity

Full Information

NCT ID

NCT00921661

First Posted

June 15, 2009

Last Updated

November 8, 2012

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00921661

Brief Title

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

Official Title

A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Neoplasm Metastasis

Keywords

oxaliplatin, 5-FU, Folinic Acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AVE0005 (aflibercept)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AVE0005 (aflibercept)

Intervention Description

IV infusion

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT) combination with FOLFIRI

Time Frame

During the first 2 cycles (4 weeks) of study treatment

Secondary Outcome Measure Information:

Title

physical examination, laboratory safety tests, adverse events

Time Frame

up to 60 days after last treatment

Title

Pharmacokinetics

Time Frame

up to 90 days after last treatment

Title

Tumor burden, endogenous free VEGF

Time Frame

every 3 cycles

Title

Immunogenicity

Time Frame

up to 90 days after last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23179335

Citation

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.

Results Reference

derived

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

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