Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Dose Escalation Study of Hydroxyurea in Combination With SCH900776 in Advanced Malignant Solid Tumors
This is an open label Phase I study with two parts. Part Two with SCH900776 in combination
with hydroxyurea will not be pursued at this time.
Part One investigates monotherapy with oral hydroxyurea. The primary objective is to
determine whether a tolerated dose (TD) of hydroxyurea as a single agent can increase the
percentage of tumor cells in S and G2 phase of the cell cycle. For this reason, all patients
in Part One must have a tumor lesion accessible for a skin punch biopsy. Tumor biopsies will
be obtained on two separate occasions: prior to hydroxyurea and at 16-18h after starting
hydroxurea therapy on day 1 only.
A baseline 12-lead ECG will be obtained from each study participant. Single-agent
hydroxyurea will be administered on days 1, 8 and 15 of a 28 day cycle, for ONE cycle only.
On these days oral hydroxyurea will be started in the late afternoon and administered every
4 hours for a total of 6 doses.
Venous (up to 10 mL) blood samples will be obtained at time zero (pretreatment), 30 min, 1h,
1.5 2, 2.5, 3.0, 3.5 and 4h following the first oral dose of hydroxyurea, and pretreatment
and at the same times following the sixth oral dose of hydroxyurea (i.e., 20, 20.5, 21,
21.5, 22, 22.5, 23, 23.5 and 24 h).
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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