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

Completed · Phase 1

Conditions studied: Neoplasms, Malignant Carcinoma

In brief

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.

Key facts

Study ID

NCT00838539

Run by

Puma Biotechnology, Inc.

People needed

63

Starts

2009-04-01

Expected to finish

2013-12-01

Last updated by the study team

2018-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Institut Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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