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

NCT00266877 | Completed Phase 2 Results

• 2 other identifiers: 3144A1-200B1891037
• Study Type: interventional
• Target: 172
• Locations: 5 countries
• Sites: 19

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

Keywords

Lung Cancer; HKI-272; Neratinib; Nerlynx

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer

  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.

  From first dose date to progression/death or last tumor assessment, up to three years.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (3)

Prior Tarceva or Iressa With EGFR Mutation

EXPERIMENTAL

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

Drug: HKI-272

Prior Tarceva or Iressa w/o EGFR Mutation

EXPERIMENTAL

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

Drug: HKI-272

No Prior EGFR Tyrosine Kinase Inhibitor Treatment

EXPERIMENTAL

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)

Drug: HKI-272

Interventions

HKI-272 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.

Also known as: Neratinib

No Prior EGFR Tyrosine Kinase Inhibitor Treatment; Prior Tarceva or Iressa With EGFR Mutation; Prior Tarceva or Iressa w/o EGFR Mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Puma Biotechnology, Inc.: lead

Study Sites (19)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Massachusetts General Hospital, Yawkey Center for Outpatient Care

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan-Kettering

New York, New York, 10021, United States

Location

Carolinas Hematology-Oncology Associates

Charlotte, North Carolina, 28203, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-6868, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, H-1529, Hungary

Location

University of Debrecen

Debrecen, H-4012, Hungary

Location

Akademia Medyczna W Gdansku

Gdansk, 80-952, Poland

Location

Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

Otwock, 05-400, Poland

Location

Wielkopolskie Centrum Chorób Płuc i Gruźlicy

Poznan, 60-569, Poland

Location

Dolnośląskie Centrum Chorób Płuc we Wrocławiu

Wroclaw, 54-439, Poland

Location

Hospital Germans Trias I Puyol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

neratinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Director, Clinical Operations
• Organization: Puma Biotechnology, Inc.

clinicaltrials@pumabiotechnology.com

+1 (424) 248-6500

Study Officials

• Puma

  Biotechnology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 19, 2005
• Study Start: December 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Locations

US (11); ES (1); FR (1); HU (2); PL (4)