Clinical trial NCT01930552: A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2013-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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".

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with standard safety assessments (adverse events and laboratory tests)
timeFrame: Up to last treatment + 30 days
measure: Pharmacokinetics: Assessment of plasma concentrations of aflibercept, CPT-11 (irinotecan) and Fluorouracil (5-FU)
timeFrame: Up to last aflibercept administration + 90 days
Secondary outcomes:
measure: Anti-tumor activity assessment - overall response rate
timeFrame: Up to 17 Weeks
measure: Anti-tumor activity assessment - duration response
timeFrame: Up to 17 Weeks
measure: Anti-aflibercept antibody detection
timeFrame: Up to last aflibercept administration + 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156002
city: Guangzhou
country: China
facility: Investigational Site Number 156001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: