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

NCT ID: NCT00266877

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-01-31

Brief Summary

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

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prior Tarceva or Iressa With EGFR Mutation

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

Group Type: EXPERIMENTAL

HKI-272

Intervention Type: DRUG

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.

Prior Tarceva or Iressa w/o EGFR Mutation

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

Group Type: EXPERIMENTAL

HKI-272

Intervention Type: DRUG

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.

No Prior EGFR Tyrosine Kinase Inhibitor Treatment

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)

Group Type: EXPERIMENTAL

HKI-272

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Neratinib

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Puma

Role: STUDY_DIRECTOR

Biotechnology

Locations

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

Countries

United States; France; Hungary; Poland; Spain

Other Identifiers

B1891037

Identifier Type: -

Identifier Source: secondary_id

3144A1-200

Identifier Type: -

Identifier Source: org_study_id