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

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ClinicalTrials.gov Identifier: NCT01930552
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : January 7, 2015
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: Aflibercept AVE0005 Drug: Leucovorin Drug: Irinotecan Drug: 5-Fluorouracil Phase 1

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".


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks
Drug: Aflibercept AVE0005
Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Drug: Leucovorin
Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Drug: Irinotecan
Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Drug: 5-Fluorouracil
Pharmaceutical form:Solution for infusion Route of administration: Intravenous




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930552


Locations
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China
Investigational Site Number 156002
Beijing, China, 100071
Investigational Site Number 156001
Guangzhou, China, 510060
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01930552     History of Changes
Other Study ID Numbers: TCD11470
U1111-1115-7286 ( Other Identifier: UTN )
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Neoplasms
Irinotecan
Fluorouracil
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs