Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00266877 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 2
Development phase
172
Enrollment target

NCT00266877: Completed Phase 2 study, sponsored by Puma Biotechnology.

NCT00266877 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 172 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00266877, a Phase 2 study, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 2
Development phase
172 participants
Enrollment target

Study Summary

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

Primary Outcome

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.

Interventions

  • DRUG HKI-272

Trial Details

FieldValue
Enrollment Target 172 participants
Start Date 2005-12
Est. Completion 2009-01
Phase Phase 2
Puma Biotechnology

28 total trials

What the finished NCT00266877 record still lists

NCT00266877 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).

The record links to 0 conditions, and to 1 intervention - of which HKI-272 is the first listed.

NCT00266877 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00266877 about?

NCT00266877 is a clinical study titled "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.

What is the current status of trial NCT00266877?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2005-12. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00266877?

The interventions under investigation include: HKI-272 (DRUG).

Who is sponsoring clinical trial NCT00266877?

This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00266877's enrollment target sits among peer trials

172 397th of 2000 higher than 1,603 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04801797 · 172 participants · Phase 2

    Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

  • NCT04867317 · 172 participants · Phase 3

    Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

  • NCT05357040 · 172 participants · Phase 2

    Antidepressant Effects of Nitrous Oxide

  • NCT05587517 · 172 participants · Phase 2

    A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00266877, the US trial registry maintained by the National Library of Medicine. NCT00266877 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.