A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies

Neoplasm Malignant Clinical Trial

Official title:

A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Aflibercept in Combination With FOLFIRI Administrated Every 2 Weeks in Chinese Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930552
• Other study ID #: TCD11470
• Secondary ID: U1111-1115-7286
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2013
• Last updated: January 6, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Total duration of the study per patient is in the range of 17 to 29 weeks.

This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• Aflibercept AVE0005
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
• Leucovorin
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
• Irinotecan
Pharmaceutical form:Solution for infusion Route of administration: Intravenous
• 5-Fluorouracil
Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Locations

Country	Name	City	State
China	Investigational Site Number 156002	Beijing
China	Investigational Site Number 156001	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with standard safety assessments (adverse events and laboratory tests)		Up to last treatment + 30 days	Yes
Primary	Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)		Up to last aflibercept administration + 90 days	No
Secondary	Anti-tumor activity assessment - overall response rate		Up to 17 Weeks	No
Secondary	Anti-tumor activity assessment - duration response		Up to 17 Weeks	No
Secondary	Anti-aflibercept antibody detection		Up to last aflibercept administration + 90 days	Yes