Status:
COMPLETED
Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Neoplasms
Malignant Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 prelimi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00838539
Start Date
April 1 2009
End Date
December 1 2013
Last Update
September 18 2018
Active Locations (5)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215