Neoplasm Malignant
Conditions
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.
Interventions
Pharmaceutical form: solution for infusion Route of administration: intravenous
Pharmaceutical form: solution for infusion Route of administration: intravenous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity (DLT) | 3 weeks (cycle 1) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of aflibercept | up to last aflibercept administration +90 days |
| Pharmacokinetic parameters of docetaxel | cycle 1 |
| 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 |
| Immunogenicity of Aflibercept | up to last aflibercept administration+90 days |
| Endogenous free VEGF | up to last aflibercept administration+30 days |
| 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 |
Countries
China
Outcome results
None listed