Status:
COMPLETED
Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
Eligibility Criteria
Inclusion
- Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
- Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
- Tumor sample available and adequate for analysis.
- At least one measurable target lesion.
- Adequate cardiac, kidney, and liver function
- Adequate blood counts
Exclusion
- More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
- Significant cardiac disease or dysfunction.
- Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2.
- Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
- Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
- Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- Inability or unwillingness to swallow HKI-272 capsules.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00266877
Start Date
December 1 2005
End Date
January 1 2009
Last Update
April 13 2018
Active Locations (19)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
3
Massachusetts General Hospital, Yawkey Center for Outpatient Care
Boston, Massachusetts, United States, 02114
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455