Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

In brief

The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

Key facts

Study ID

NCT00266877

Run by

Puma Biotechnology, Inc.

People needed

172

Starts

2005-12-01

Expected to finish

2009-01-01

Last updated by the study team

2018-04-13

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Midwestern Regional Medical Center — Zion, Illinois, United States
• Massachusetts General Hospital, Yawkey Center for Outpatient Care — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Memorial Sloan-Kettering — New York, New York, United States
• Carolinas Hematology-Oncology Associates — Charlotte, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Institut Gustave Roussy — Villejuif, France
• Országos Korányi TBC és Pulmonológiai Intézet — Budapest, Hungary
• University of Debrecen — Debrecen, Hungary
• Akademia Medyczna W Gdansku — Gdansk, Poland
• Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy — Otwock, Poland
• Wielkopolskie Centrum Chorób Płuc i Gruźlicy — Poznan, Poland
• Dolnośląskie Centrum Chorób Płuc we Wrocławiu — Wroclaw, Poland
• Hospital Germans Trias I Puyol — Badalona, Barcelona, Spain

Full record on ClinicalTrials.gov

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