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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: afatinib 20mg; Drug: afatinib 40mg; Drug: vinorelbine IV 25 or 20mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214616

1200.84

Details and patient eligibility

About

• 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.

Enrollment: 17 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

afatinib and vinorelbine IV

Experimental group

Description:

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

Treatment:

Drug: vinorelbine IV 25 or 20mg/m2

Drug: afatinib 40mg

Drug: afatinib 20mg