NCT01148615

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

June 21, 2010

Last Update Submit

January 12, 2012

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

  • Dose-Limiting Toxicity (DLT)

    3 weeks (cycle 1)

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Aflibercept/ docetaxel

EXPERIMENTAL

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)Drug: Docetaxel (XRP6976)

Interventions

Aflibercept (AVE0005)DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Aflibercept/ docetaxel
Docetaxel (XRP6976)DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Aflibercept/ docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Investigational Site Number 156001

Guangzhou, 510060, China

Location

Related Publications (1)

  • 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.

    PMID: 25531046DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

afliberceptDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

January 13, 2012

Record last verified: 2012-01

Locations

CN(1)