Clinical trial · Interventional
A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aflibercept (AVE0005) | Drug | Aflibercept | ALIAS |
| Docetaxel (XRP6976) | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aflibercept/ docetaxel
- description
- 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
- interventionNames
- Drug: Aflibercept (AVE0005)
- Drug: Docetaxel (XRP6976)
Primary outcomes (1)
- measure
- Dose-Limiting Toxicity (DLT)
- timeFrame
- 3 weeks (cycle 1)
Secondary outcomes (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHuang 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 25531046