Clinical trial · Interventional
Study Evaluating HKI-272 in Tumors
An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors
NCT00146172CI-TRIAL-00034887completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neratinib | Drug | Neratinib | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Neratinib 40 mg
- interventionNames
- Drug: neratinib
- type
- EXPERIMENTAL
- label
- Neratinib 80 mg
- interventionNames
- Drug: neratinib
- type
- EXPERIMENTAL
- label
- Neratinib 120 mg
- interventionNames
- Drug: neratinib
- type
- EXPERIMENTAL
- label
- Neratinib 180 mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Her2/neu or Her1/EGFR positive cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Exclusion Criteria: * Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m\^2 * Patients with significant cardiac risk factors * Active central nervous system metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.