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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BIBW 2992 high (50mg) dosage; Drug: Vinorelbine per os 80 mg/m²; Drug: Vinorelbine i.v. 25 mg/m²; Drug: BIBW 2992 low (20mg) dosage; Drug: BIBW 2992 medium (40mg) dosage; Drug: Vinorelbine per os 60 mg/m²

Study type: Interventional

Funder types: Industry

Identifiers

NCT00906698

1200.69

2008-006290-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

BIBW 2992 and vinorelbine i.v

Experimental group

Description:

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

Treatment:

Drug: Vinorelbine i.v. 25 mg/m²

Drug: BIBW 2992 high (50mg) dosage

Drug: BIBW 2992 low (20mg) dosage

Drug: BIBW 2992 medium (40mg) dosage

BIBW 2992 and vinorelbine per os

Experimental group

Description:

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

Treatment:

Drug: BIBW 2992 high (50mg) dosage

Drug: BIBW 2992 low (20mg) dosage

Drug: Vinorelbine per os 80 mg/m²

Drug: BIBW 2992 medium (40mg) dosage

Drug: Vinorelbine per os 60 mg/m²