drugset
drugset / Trial / NCT01214616

BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours

NCT01214616 ↗

Phase 1 Completed 17 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

* To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT); * To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.

Timeline

Start
2010-10-01
Primary completion
2013-05-01
Completion
2013-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 20 mg Oral
Subject Afatinib Small molecule 40 mg Oral
Subject Vinorelbine Small molecule 20 mg/m2 Intravenous
Subject Vinorelbine Small molecule 25 mg/m2 Intravenous

Indications

neoplasm