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

NCT ID: NCT01148615

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-12-31

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)

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.

Conditions

Neoplasm Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Aflibercept (AVE0005)

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Docetaxel (XRP6976)

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Interventions

Aflibercept (AVE0005)

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

Docetaxel (XRP6976)

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Investigational Site Number 156001

Guangzhou, , China

Countries

China

References

Huang Y, Zou BY, Zhao LP, Zhao HY, Zhao YY, Xue C, Zhang JW, Xu F, Chen LK, Liu JL, Hu ZH, Wu X, Zhang J, Ma YX, Wei CL, Ma Y, Zhang L. Phase I dose-escalation study of aflibercept plus docetaxel in nasopharyngeal carcinoma and other solid tumors. Future Oncol. 2014 Dec;10(16):2579-91. doi: 10.2217/fon.14.206.

Reference Type: DERIVED

PMID: 25531046 (View on PubMed)

Other Identifiers

U1111-1116-5774

Identifier Type: OTHER

Identifier Source: secondary_id

TCD11382

Identifier Type: -

Identifier Source: org_study_id