Neoplasm Malignant Clinical Trial
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
Verified date | January 2012 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Sanofi-Aventis Investigational Site Number 156001 | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Sanofi | Regeneron Pharmaceuticals |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-Limiting Toxicity (DLT) | 3 weeks (cycle 1) | No | |
Secondary | 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 | Yes | |
Secondary | Pharmacokinetic parameters of aflibercept | up to last aflibercept administration +90 days | No | |
Secondary | Pharmacokinetic parameters of docetaxel | cycle 1 | No | |
Secondary | 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 | No | |
Secondary | Immunogenicity of Aflibercept | up to last aflibercept administration+90 days | Yes | |
Secondary | Endogenous free VEGF | up to last aflibercept administration+30 days | No |
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