The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.
Institut Gustave-Roussy
Villejuif, France
St. James University Hospital
Leeds, United Kingdom
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose
Time frame: First cycle
Assessment of Adverse Events (based on CTCAE version 3.0)
Time frame: All cycles
Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters.
Time frame: First 2 cycles
Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment.
Time frame: First cycle
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