Clinical trial NCT01148615: A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2010-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: 3 weeks (cycle 1)
Secondary outcomes:
measure: Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities
timeFrame: Up to 30 days after last administration within a maximum follow up of 18 months
measure: Pharmacokinetic parameters of aflibercept
timeFrame: up to last aflibercept administration +90 days
measure: Pharmacokinetic parameters of docetaxel
timeFrame: cycle 1
measure: Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
timeFrame: up to a maximum follow-up of 18 months
measure: Immunogenicity of Aflibercept
timeFrame: up to last aflibercept administration+90 days
measure: Endogenous free VEGF
timeFrame: up to last aflibercept administration+30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sanofi-Aventis Investigational Site Number 156001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.