Conditions: Advanced Malignant Solid Tumors
Keywords: HKI-272 Vinorelbine Combination Solid Tumor Neratinib Nerlynx PB-272
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
The purposes of this study are to evaluate the safety and tolerability of neratinib in combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors in Japanese patients.

Detailed description:

Arms:
arm 1: Neratinib: 240 mg administered daily by mouth continuously, Vinorelbine: 25 mg/m\^2 administered IV on Day 1 and 8 of 21 day cycle

Interventions: intervention 1: Neratinib intervention 2: Vinorelbine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: