Clinical trial · Interventional
A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients
A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in 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)
The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients. The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aflibercept (AVE0005) | Drug | Aflibercept | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
- timeFrame
- during the first cycle of study treatment
Secondary outcomes (3)
- measure
- safety: physical examination, laboratory safety tests, adverse events
- timeFrame
- treatment period
- measure
- pharmacokinetic values
- timeFrame
- treatment period
- measure
- objective response rate
- timeFrame
- treatment period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cancer patients without standard of care * ECOG performance status 0, 1, or 2 * Adequate organ and bone marrow function Exclusion Criteria: * Need for a major surgery or radiation therapy during the study * History of hypersensitivity to S-1 * Known dihydropyrimidine dehydrogenase deficiency * Uncontrolled hypertension * History of brain metastases * Ascites requiring drainage * Pregnancy or breastfeeding * Patients who have previously been treated with AVE0005 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available