Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00266877
- Lead Sponsor
- Puma Biotechnology, Inc.
- Brief Summary
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prior Tarceva or Iressa With EGFR Mutation HKI-272 HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening Prior Tarceva or Iressa w/o EGFR Mutation HKI-272 HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening No Prior EGFR Tyrosine Kinase Inhibitor Treatment HKI-272 HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, \< or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)
- Primary Outcome Measures
Name Time Method Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer From first dose date to progression/death or last tumor assessment, up to three years. Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer From first dose date to progression/death or last tumor assessment, up to three years. Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease \>= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer From start date of response to first PD, assessed up to three years after the first randomization. Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer From first dose date to progression/death, assessed up to three years. Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Trial Locations
- Locations (19)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Institut Gustave Roussy
🇫🇷Villejuif, France
Carolinas Hematology-Oncology Associates
🇺🇸Charlotte, North Carolina, United States
Akademia Medyczna W Gdansku
🇵🇱Gdansk, Poland
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Massachusetts General Hospital, Yawkey Center for Outpatient Care
🇺🇸Boston, Massachusetts, United States
Memorial Sloan-Kettering
🇺🇸New York, New York, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Wielkopolskie Centrum Chorób Płuc i Gruźlicy
🇵🇱Poznan, Poland
Országos Korányi TBC és Pulmonológiai Intézet
ðŸ‡ðŸ‡ºBudapest, Hungary
University of Debrecen
ðŸ‡ðŸ‡ºDebrecen, Hungary
Dolnośląskie Centrum Chorób Płuc we Wrocławiu
🇵🇱Wrocław, Poland
Hospital Germans Trias I Puyol
🇪🇸Badalona, Barcelona, Spain
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
🇵🇱Otwock, Poland