NCT00921661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

June 15, 2009

Last Update Submit

November 8, 2012

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Keywords

oxaliplatin5-FUFolinic Acid

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicity (DLT) combination with FOLFIRI

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

Secondary Outcomes (4)

  • physical examination, laboratory safety tests, adverse events

    up to 60 days after last treatment

  • Pharmacokinetics

    up to 90 days after last treatment

  • Tumor burden, endogenous free VEGF

    every 3 cycles

  • Immunogenicity

    up to 90 days after last treatment

Study Arms (1)

AVE0005 (aflibercept)

EXPERIMENTAL
Drug: AVE0005 (aflibercept)

Interventions

AVE0005 (aflibercept)DRUG

IV infusion

AVE0005 (aflibercept)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23179335DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

JP(1)