A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01148615

Collaborator

Regeneron Pharmaceuticals (Industry)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.

Secondary Objectives:

To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel
To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination
To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease
To evaluate the immunogenicity of IV aflibercept
To measure endogenous free Vascular Endothelial Growth Factor (VEGF)

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Malignant	Drug: Aflibercept (AVE0005) Drug: Docetaxel (XRP6976)	Phase 1

Detailed Description

The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aflibercept/ docetaxel Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel. Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks	Drug: Aflibercept (AVE0005) Pharmaceutical form: solution for infusion Route of administration: intravenous Drug: Docetaxel (XRP6976) Pharmaceutical form: solution for infusion Route of administration: intravenous

Arm

Intervention/Treatment

Experimental: Aflibercept/ docetaxel

Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel. Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks

Drug: Aflibercept (AVE0005)

Pharmaceutical form: solution for infusion Route of administration: intravenous

Drug: Docetaxel (XRP6976)

Pharmaceutical form: solution for infusion Route of administration: intravenous

Outcome Measures

Primary Outcome Measures

Dose-Limiting Toxicity (DLT) [3 weeks (cycle 1)]

Secondary Outcome Measures

Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities [Up to 30 days after last administration within a maximum follow up of 18 months]
Pharmacokinetic parameters of aflibercept [up to last aflibercept administration +90 days]
Pharmacokinetic parameters of docetaxel [cycle 1]
Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [up to a maximum follow-up of 18 months]
Immunogenicity of Aflibercept [up to last aflibercept administration+90 days]
Endogenous free VEGF [up to last aflibercept administration+30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria :

Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.

Exclusion criteria :

Squamous histology/cytology lung cancer
Need for a major surgical procedure or radiation therapy during the study
Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
Cumulative radiation therapy to >25% of the total bone marrow
History of brain metastases
Eastern Cooperative Oncology Group(ECOG)>1
Prior docetaxel treatment but have not been appropriate for safety reasons
Inadequate organ and bone marrow function
Uncontrolled hypertension
Evidence of clinically significant bleeding diathesis or underlying coagulopathy

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Investigational Site Number 156001	Guangzhou		China	510060

Sponsors and Collaborators

Sanofi
Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT01148615

Other Study ID Numbers:

TCD11382
U1111-1116-5774

First Posted:

Jun 22, 2010

Last Update Posted:

Jan 13, 2012

Last Verified:

Jan 1, 2012

Additional relevant MeSH terms:

Neoplasms

Docetaxel

Aflibercept

Study Results

No Results Posted as of Jan 13, 2012