A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

Phase 1 Completed 12 enrolled Sanofi Regeneron Pharmaceuticals · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2007-10
Primary completion: 2012-07
Completion: 2012-07

Publications

Sunakawa 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	2 mg/kg	Intravenous
Subject	Aflibercept	Protein / enzyme biologic	4 mg/kg	Intravenous
Subject	Aflibercept	Protein / enzyme biologic	6 mg/kg	Intravenous
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous

A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

Summary

Timeline

Publications

Drugs

Indications