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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasm Malignant

Treatments: Drug: Irinotecan; Drug: Leucovorin; Drug: Aflibercept AVE0005; Drug: 5-Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01930552

TCD11470

U1111-1115-7286 (Other Identifier)

Details and patient eligibility

About

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.

Full 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".

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: 5-Fluorouracil

Drug: Irinotecan

Drug: Leucovorin

Drug: Aflibercept AVE0005