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Completed

NCT Number: NCT01930552

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

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.

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Key information

Conditions

Neoplasm Malignant Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 156002, Beijing, China

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About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AFLIBERCEPT AVE0005

Drug

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Leucovorin

Drug

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Irinotecan

Drug

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

5-fluorouracil

Drug

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Primary outcomes

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

    Time frame: Up to last treatment + 30 days

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

    Time frame: Up to last aflibercept administration + 90 days

Secondary outcomes

  1. Anti-tumor activity assessment - overall response rate

    Time frame: Up to 17 Weeks

  2. Anti-tumor activity assessment - duration response

    Time frame: Up to 17 Weeks

  3. Anti-aflibercept antibody detection

    Time frame: Up to last aflibercept administration + 90 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2013
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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