A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
- 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.
- 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
- Symptomatic or prior history of non-infectious interstitial pneumonitis.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the Maximum Tolerated Dose (MTD) toxicity contour of the combination of neratinib and temsirolimus.
Outcome Time Frame:
Approximately 12 months
United States: Food and Drug Administration
- Malignant Carcinoma
- Neratinib in combination with Temsirolimus
- solid tumors
- phase 1
- dose finding study
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