Phase 1
Completed N=73
Study Evaluating HKI-272 in Tumors
Source: ClinicalTrials.gov NCT00146172 ↗Enrolled (actual)
73
Serious AEs
37.5%
Results posted
Feb 2018
Primary outcomePrimary: Dose Limiting Toxicity (DLT) — 0; 0; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity (DLT) |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Maximum Tolerated Dose (MTD) |
320 | — |
| SECONDARY Number of Participants With Best Overall Response |
8; 0; 8; 1; 6; 7 | — |
| SECONDARY Duration of Response |
4.8; 4.8 | — |
| SECONDARY Progression Free Survival |
3.6; 3.5; 1.9 | — |
| SECONDARY Objective Response Rate |
32.0; 0; 13.3 | — |
| SECONDARY Clinical Benefit Rate |
36.0; 42.9; 25.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00146172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.