Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-01-31

Brief Summary

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To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIBW 2992 and vinorelbine i.v

Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine i.v.

Group Type EXPERIMENTAL

BIBW 2992 low (20mg) dosage

Intervention Type DRUG

Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

BIBW 2992 medium (40mg) dosage

Intervention Type DRUG

Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

BIBW 2992 high (50mg) dosage

Intervention Type DRUG

Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.

Vinorelbine i.v. 25 mg/m²

Intervention Type DRUG

Patients will receive 25 mg/m² of Vinorelbine i.v.

BIBW 2992 and vinorelbine per os

Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine per os.

Group Type EXPERIMENTAL

BIBW 2992 low (20mg) dosage

Intervention Type DRUG

Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

BIBW 2992 medium (40mg) dosage

Intervention Type DRUG

Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

BIBW 2992 high (50mg) dosage

Intervention Type DRUG

Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.

Vinorelbine per os 60 mg/m²

Intervention Type DRUG

Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15

Vinorelbine per os 80 mg/m²

Intervention Type DRUG

Patients will receive 80 mg/m² Vinorelbine per os at J22

Interventions

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BIBW 2992 low (20mg) dosage

Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

Intervention Type DRUG

BIBW 2992 medium (40mg) dosage

Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

Intervention Type DRUG

BIBW 2992 high (50mg) dosage

Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.

Intervention Type DRUG

Vinorelbine per os 60 mg/m²

Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15

Intervention Type DRUG

Vinorelbine per os 80 mg/m²

Patients will receive 80 mg/m² Vinorelbine per os at J22

Intervention Type DRUG

Vinorelbine i.v. 25 mg/m²

Patients will receive 25 mg/m² of Vinorelbine i.v.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of malignancy that is now advanced, non resectable and/or metastatic
* Tumours historically known to overexpress EGFR and/or HER2

Exclusion Criteria

* Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of therapy or concomitantly with this trial.
* Prior treatment with EGFR inhibiting drugs within the past two weeks before the start of therapy or concomitantly with this trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No