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Completed

NCT Number: NCT00266877

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

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

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Gustave Roussy, Villejuif, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Neratinib

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer

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

    Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks 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; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  2. Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer

    Time frame: From start date of response to first PD, assessed up to three years after the first randomization.

    Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, 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.

  3. Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer

    Time frame: From first dose date to progression/death, assessed up to three years.

    Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 19, 2005
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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