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

NCT01214616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-02-07

Study results available
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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.

Conditions

  • Neoplasms

Interventions

DRUG

afatinib 20mg

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

DRUG

afatinib 40mg

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

DRUG

vinorelbine IV 25 or 20mg/m2

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01214616 on ClinicalTrials.gov