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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-01

Study Completion Date

2013-05-01

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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afatinib and vinorelbine IV

patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV

Group Type EXPERIMENTAL

afatinib 20mg

Intervention Type DRUG

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

afatinib 40mg

Intervention Type DRUG

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

vinorelbine IV 25 or 20mg/m2

Intervention Type DRUG

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

Interventions

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afatinib 20mg

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

Intervention Type DRUG

afatinib 40mg

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

Intervention Type DRUG

vinorelbine IV 25 or 20mg/m2

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of malignancy that is advanced and for which standard therapies do not exist or are no longer effective.
* Life expectancy at least 12 weeks
* Eastern Cooperative Oncology Group Performance Status 0 or 1
* Adequate hepatic, renal, haematologic and other organ function
* Written informed consent

Exclusion Criteria

* Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks
* Prior treatment with afatinib and or vinorelbine
* Clinically significant active infectious disease

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No