Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.

Inclusion Criteria:

• Pathologic diagnosis of advanced or metastatic solid tumor.
• Measurable disease per Response Criteria in Solid Tumors (RECIST criteria).
• Incurable cancer, with disease progression following at least 1 conventional or standard therapy for locally advanced or metastatic disease.
• Negative pregnancy test for women of child bearing potential.

Exclusion Criteria:

• Chronic treatment with corticosteroids.
• Primary central nervous system (CNS) tumors and active metastases.
• Presence of clinically significant or uncontrolled cardiac disease.
• Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
• Symptomatic or prior history of non-infectious interstitial pneumonitis.