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

Puma Biotechnology

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Treatments: Drug: HKI-272

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266877

B1891037

3144A1-200

Details and patient eligibility

About

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

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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172 participants in 3 patient groups

Prior Tarceva or Iressa With EGFR Mutation

Experimental group

Description:

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

Treatment:

Drug: HKI-272

Prior Tarceva or Iressa w/o EGFR Mutation

Experimental group

Description:

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

Treatment:

Drug: HKI-272

No Prior EGFR Tyrosine Kinase Inhibitor Treatment

Experimental group

Description:

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)

Treatment:

Drug: HKI-272