Ovarian Cancer Clinical Trial
Official title:
LDE225 in Combination With Paclitaxel in Patients With Advanced Solid Tumors - A Multicenter Phase I Trial
The primary aim of this trial is to establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of LDE225 given in combination with standard doses of paclitaxel in patients with advanced solid tumors. In addition, the preliminary anti-tumor activity of this combination will be assessed, in particular in ovarian cancer.
This is a multicenter, open label phase I dose-escalation trial of LDE225 administered once
daily (OD) with Paclitaxel administered weekly for three weeks (days 1, 8, 15) in 28-day
cycles in adult patients with advanced solid tumors that have progressed despite standard
therapy.
The trial will consist of three parts. In Part A (dose escalation following a standard 3+3
design), patients with previously treated advanced solid tumors will receive escalating doses
of LDE225 in combination with standard Paclitaxel doses, to define the MTD and the RP2D of
LED225 OD that can be given in combination with standard doses of Paclitaxel. Once the MTD
and RP2D is established in 6 patients, then part B will start.
Part B and C are expansion cohorts in patients with advanced platinum-resistant ovarian
cancer (6 patients each) to further evaluate the safety of the combination and to assess for
any preliminary antitumor activity.
In Part B, any prior taxane therapy must have been administered on a 3-week schedule. In Part
C, prior taxane therapy must have been administered on weekly schedule and has to be followed
by a wash-out period of at least 6 months.
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