Clinical trial NCT00266877: Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
Official title: A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Keywords: Lung Cancer
HKI-272
Neratinib
Nerlynx
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-19
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
timeFrame: From first dose date to progression/death or last tumor assessment, up to three years.
Secondary outcomes:
measure: Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer
timeFrame: From first dose date to progression/death or last tumor assessment, up to three years.
measure: Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer
timeFrame: From start date of response to first PD, assessed up to three years after the first randomization.
measure: Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer
timeFrame: From first dose date to progression/death, assessed up to three years.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital, Yawkey Center for Outpatient Care
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering
state: New York
city: Charlotte
country: United States
facility: Carolinas Hematology-Oncology Associates
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Gdansk
country: Poland
facility: Akademia Medyczna W Gdansku
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Chorób Płuc i Gruźlicy
city: Wrocław
country: Poland
facility: Dolnośląskie Centrum Chorób Płuc we Wrocławiu
city: Badalona
country: Spain
facility: Hospital Germans Trias I Puyol
state: Barcelona
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References: