Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
Checked against the public recordLast updated Apr 13, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Puma Biotechnology, Inc.
- Interventions being studied
- Drug: HKI-272
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Midwestern Regional Medical CenterZion, Illinois
- Massachusetts General Hospital, Yawkey Center for Outpatient CareBoston, Massachusetts
- University of MinnesotaMinneapolis, Minnesota
- Memorial Sloan-KetteringNew York, New York
- Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina
- Case Western Reserve UniversityCleveland, Ohio
- Cleveland ClinicCleveland, Ohio
- Vanderbilt University Medical CenterNashville, Tennessee
- Swedish Cancer InstituteSeattle, Washington
- Seattle Cancer Care AllianceSeattle, Washington
- Institut Gustave RoussyVillejuif
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 13, 2018. Always confirm current availability with the study team.