Clinical trial · Interventional
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients
A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks 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 dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients. The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, 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 |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- aflibercept + docetaxel
- interventionNames
- Drug: aflibercept (AVE0005)
- Drug: docetaxel
Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
- timeFrame
- first 3-week cycle
Secondary outcomes (3)
- measure
- safety: physical examination, laboratory safety tests, adverse events
- timeFrame
- up to 60 days after last treatment
- measure
- pharmacokinetic values
- timeFrame
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 or 1 * Adequate organ and bone marrow function Exclusion Criteria: * Need for a major surgery or radiation therapy during the study * History of hypersensitivity to docetaxel or polysorbate 80 * Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days * Uncontrolled hypertension * History of brain metastases * Ascites requiring drainage * Pregnancy or breastfeeding * Patients who have previously been treated with aflibercept. The investigator will evaluate whether there are other reasons why a patient may not participate.
References
Publications (1)
- DERIVEDSunakawa Y, Takahashi K, Kawaguchi O, Yamamoto N. Phase I study of aflibercept in combination with docetaxel in Japanese patients with advanced solid malignancies. Invest New Drugs. 2022 Oct;40(5):1032-1041. doi: 10.1007/s10637-022-01267-x. Epub 2022 Jun 30. PMID 35771301