Phase 1
Completed N=57
Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT00424632 ↗Enrolled (actual)
57
Serious AEs
24.6%
Results posted
Jun 2012
Primary outcomePrimary: Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3 — 0; 0; 0; 0 participants
Summary
The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
0.1920; 0.6470; 0.9010; 1.965; 3.724; 3.773 | — |
| SECONDARY Time for Maximum Observed Serum Concentration (Tmax) |
2.00; 1.00; 24.0; 1.50; 2.00; 2.00 | — |
| SECONDARY Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) |
— | — |
| SECONDARY Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ). |
2.957; 10.09; 17.68; 22.99; 47.95; 49.33 | — |
| SECONDARY Minimum Observed Serum Trough Concentration (Cmin) |
0.05440; 0.2330; 0.3110; 0.4521; 1.019; 1.061 | — |
| SECONDARY Observed Serum Accumulation Ratio (Rac) |
1.054; 1.503; 1.247 | — |
| SECONDARY Terminal Half-life (t 1/2) |
— | — |
| SECONDARY Urine Pharmacokinetics |
— | — |
| SECONDARY Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET) |
— | — |
| SECONDARY Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC) |
— | — |
| SECONDARY Number of Participants With Objective Tumor Response |
— | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735 |
— | — |
| SECONDARY Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue |
— | — |
Eligibility Criteria
Inclusion Criteria
- Metastatic solid tumor resistant to standard therapy or for which no standard therapy is available
- Adequate bone marrow, liver and kidney function
Exclusion Criteria
- Brain metastases that are symptomatic and/or require treatment with steroids and/or anticonvulsants, or brain metastases that have been treated within 3 months prior to study start
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
Data sourced from ClinicalTrials.gov (NCT00424632). 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.