Conditions: Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief summary:
* 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.

Detailed description:

Arms:
arm 1: patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV

Interventions: intervention 1: afatinib 20mg intervention 2: afatinib 40mg intervention 3: vinorelbine IV 25 or 20mg/m2
Intervention descriptions: intervention 1: patient to receive afatinib low dose po daily in combination with vinorelbine iv intervention 2: patient to receive afatinib high dose po daily in combination with vinorelbine iv intervention 3: patient to receive standard dose vinorelbine once a week for four times per cycle

Protocol document: