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A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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Trial Information

A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate for neratinib in patients with non-small cell lung cancer

Outcome Time Frame:

At screening, after 1 month of treatment, and then every 2 months throughout the study

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

January 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Lung Cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Bristol, Tennessee  37620