Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00146172 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating HKI-272 in Tumors
A Phase 1 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT00146172: Completed Phase 1 study, sponsored by Puma Biotechnology.
NCT00146172 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00146172, a Phase 1 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.
Primary Outcome
DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.
Interventions
- DRUG neratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2003-11 |
| Est. Completion | 2007-01 |
| Phase | Phase 1 |
What the finished NCT00146172 record still lists
NCT00146172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 1 intervention - of which neratinib is the first listed.
NCT00146172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00146172 about?
NCT00146172 is a clinical study titled "Study Evaluating HKI-272 in Tumors". The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.
What is the current status of trial NCT00146172?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2003-11. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00146172?
The interventions under investigation include: neratinib (DRUG).
Who is sponsoring clinical trial NCT00146172?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00146172's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT03661307 · 73 participants · Phase 1
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
- NCT05386108 · 73 participants · Phase 1
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
- NCT05961592 · 73 participants · Phase 1
R-2487 in Patients With Rheumatoid Arthritis
- NCT06150664 · 73 participants · Phase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
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