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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00266877
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer
Study Start Date : December 2005
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Neratinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Peak plasma concentration of neratinib [ Time Frame: Prior to the first dose and on day 1 of months 2 through 6 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266877


  Show 25 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
More Information

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00266877     History of Changes
Other Study ID Numbers: 3144A1-200
B1891037
First Posted: December 19, 2005    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms