CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
afatinib 20mg +2 moredrug
Likely dose
afatinib 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01214616
NCT01214616Phase 1Completed
CompareCT.gov

An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours

Boehringer Ingelheim·interventional·Posted Oct 5, 2010·Updated Feb 7, 2025

In Brief

A Phase 1 clinical trial evaluating afatinib 20mg, afatinib 40mg, and 1 other intervention for Neoplasms. Completed, enrolled 17 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.7 years ago

Interventions

afatinib 20mgdrug

patient to receive afatinib low dose po daily in combination with vinorelbine iv

afatinib 40mgdrug

patient to receive afatinib high dose po daily in combination with vinorelbine iv

vinorelbine IV 25 or 20mg/m2drug

patient to receive standard dose vinorelbine once a week for four times per cycle