NCT01930552

Brief Summary

Primary Objective: 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 14, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

August 14, 2013

Last Update Submit

January 6, 2015

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (2)

  • Number of patients with standard safety assessments (adverse events and laboratory tests)

    Up to last treatment + 30 days

  • Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)

    Up to last aflibercept administration + 90 days

Secondary Outcomes (3)

  • Anti-tumor activity assessment - overall response rate

    Up to 17 Weeks

  • Anti-tumor activity assessment - duration response

    Up to 17 Weeks

  • Anti-aflibercept antibody detection

    Up to last aflibercept administration + 90 days

Study Arms (1)

Cohort 1

EXPERIMENTAL

aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks

Drug: Aflibercept AVE0005Drug: LeucovorinDrug: IrinotecanDrug: 5-Fluorouracil

Interventions

Aflibercept AVE0005DRUG

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Cohort 1
LeucovorinDRUG

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Cohort 1
IrinotecanDRUG

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Cohort 1
5-FluorouracilDRUG

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate

You may not qualify if:

  • Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational Site Number 156002

Beijing, 100071, China

Location

Investigational Site Number 156001

Guangzhou, 510060, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

afliberceptLeucovorinIrinotecanFluorouracil

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesCamptothecinAlkaloidsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

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

August 14, 2013

First Posted

August 29, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

CN(2)