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

Purpose

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

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Lung Neoplasms	Drug: HKI-272	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:

Objective response rate for neratinib in patients with non-small cell lung cancer [ Time Frame: At screening, after 1 month of treatment, and then every 2 months throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of participants with adverse events [ Time Frame: At screening, weekly for the first month, then at weeks 1 and 4 thereafter, and at the final visit ] [ Designated as safety issue: Yes ]
Effect on quality of life based on results from quality-of-life questionnaires (FACT-L and EQ-5D) [ Time Frame: At screening, on day 1 of months 3 and 5, and at the end of treamtent visit ] [ Designated as safety issue: No ]
Peak plasma concentration of neratinib [ Time Frame: Prior to the first dose and on day 1 of months 2 through 6 ] [ Designated as safety issue: No ]
Clinical benefit rate for neratinib in patients with non-small cell lung cancer [ Time Frame: At screening, after 1 month of treatment, and then every 2 months throughout the study ] [ Designated as safety issue: No ]
Duration of response for neratinib in patients with non-small cell lung cancer [ Time Frame: At screening, after 1 month of treatment, and then every 2 months throughout the study ] [ Designated as safety issue: No ]
Progression free survival for neratinib in patients with non-small cell lung cancer [ Time Frame: At screening, after 1 month of treatment, and then every 2 months throughout the study ] [ Designated as safety issue: No ]

Enrollment:	172
Study Start Date:	December 2005
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 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	Drug: HKI-272 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. Other Name: Neratinib
Experimental: B 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	Drug: HKI-272 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. Other Name: Neratinib
Experimental: C 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)	Drug: HKI-272 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. Other Name: Neratinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266877

Show 25 Study Locations

Sponsors and Collaborators

Puma Biotechnology, Inc.

Investigators

Study Director:

Puma

Biotechnology

More Information

No publications provided

Responsible Party:	Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:	NCT00266877 History of Changes
Other Study ID Numbers:	3144A1-200, B1891037
Study First Received:	December 16, 2005
Last Updated:	May 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:

Lung Cancer

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013