Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors

Sponsor
Puma Biotechnology, Inc.
Study ID
NCT00958724
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignant Solid Tumors

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2009
Status verified
Apr 2018
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: From first dose date to 21st day ]

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