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

NCT00906698 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2014-06-09

Study results available
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Summary

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

Conditions

  • Neoplasms

Interventions

DRUG

BIBW 2992 low (20mg) dosage

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

DRUG

BIBW 2992 medium (40mg) dosage

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

DRUG

BIBW 2992 high (50mg) dosage

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

DRUG

Vinorelbine per os 60 mg/m²

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

DRUG

Vinorelbine per os 80 mg/m²

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

DRUG

Vinorelbine i.v. 25 mg/m²

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • France

Study Locations

More Related Trials

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 NCT00906698 on ClinicalTrials.gov