A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Colorectal Cancer Metastatic Clinical Trial

Official title:

A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882868
• Other study ID #: EFC11885
• Secondary ID: U1111-1120-0173
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2013
• Last updated: November 12, 2015
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To assess efficacy aflibercept + FOLFIRI by objective response rate (ORR)

Secondary Objective:

To assess the following:

• safety profile

• progression free survival (PFS)

• overall survival (OS)

• pharmacokinetics (PK)

• immunogenicity

Description:

Screening is up to 24 days. Treatment period will continue until disease progression, unacceptable toxicity, or patient's refusal. Follow up period will continue until death, patient's refusal, or end of study, whichever comes first.

This trial is being conducted in Japan, 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: 62
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

Histologically or cytologically proven adenocarcinoma of the colon or rectum. Metastatic disease that is not amenable to potentially curative treatment. Patients with measurable disease. One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease. Patient who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy are also eligible.

Exclusion criteria:

Prior therapy with irinotecan. Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration.

Unresolved toxicity (grade >1) from prior anticancer therapy. Eastern Cooperative Oncology Group (ECOG) performance status >1. Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.

Other prior malignancy. Pregnant or breast-feeding women. Uncontrolled hypertension. Inadequate bone marrow function, liver function, or renal function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• aflibercept AVE0005
Pharmaceutical form:Concentrated solution for infusion Route of administration: Intravenous

Locations

Country	Name	City	State
Japan	Investigational Site Number 392011	Chiba-Shi
Japan	Investigational Site Number 392018	Chuo-Ku
Japan	Investigational Site Number 392016	Fukuoka-Shi
Japan	Investigational Site Number 392017	Fukuoka-Shi
Japan	Investigational Site Number 392001	Kashiwa-Shi
Japan	Investigational Site Number 392019	Kawasaki-Shi
Japan	Investigational Site Number 392015	Matsuyama-Shi
Japan	Investigational Site Number 392013	Mitaka-Shi
Japan	Investigational Site Number 392004	Nagoya-Shi
Japan	Investigational Site Number 392006	Osaka-Shi
Japan	Investigational Site Number 392014	Sagamihara-Shi
Japan	Investigational Site Number 392008	Sapporo-Shi
Japan	Investigational Site Number 392003	Sendai-Shi
Japan	Investigational Site Number 392009	Shimotsuke-Shi
Japan	Investigational Site Number 392012	Shinjuku-Ku
Japan	Investigational Site Number 392005	Suita-Shi
Japan	Investigational Site Number 392002	Sunto-Gun
Japan	Investigational Site Number 392010	Tsukuba-Shi
Japan	Investigational Site Number 392007	Yufu-Shi

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of overall response rate (ORR)		Up to a maximum of 1.5 years	No
Secondary	Progression free survival (PFS) - Time		Up to a maximum of 1.5 years	No
Secondary	Overall survival (OS) - Time		Up to a maximum of 2 years	No
Secondary	Incidence of treatment emergent adverse events		Up to a maximum of 2 years	Yes
Secondary	Incidence of laboratory abnormalities		Up to a maximum of 2 years	Yes
Secondary	Assessment of the titer of anti-aflibercept antibodies as a measure of the immunogenicity of aflibercept		Up to a maximum of 2 years	Yes
Secondary	Assessment of PK parameter - maximum concentration (Cmax)		Up to a maximum of 2 years	No
Secondary	Assessment of PK parameter - time to maximum concentration (tmax)		Up to a maximum of 2 years	No
Secondary	Assessment of PK parameter - area under curve (AUC)		Up to a maximum of 2 years	No
Secondary	Assessment of PK parameter - clearance (CL)		Up to a maximum of 2 years	No
Secondary	Assessment of PK parameter - distribution volume at steady state (Vss)		Up to a maximum of 2 years	No