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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 13, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.