LDE225 and Paclitaxel in Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01954355|
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : November 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Ovarian Cancer||Drug: LDE225 Drug: Paclitaxel||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LDE225 in Combination With Paclitaxel in Patients With Advanced Solid Tumors - A Multicenter Phase I Trial|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||November 2016|
Experimental: LDE225 & Paclitaxel
Phase I, Part A: LDE225: dose escalation in cohorts of 3-6 patients (days 1-28) and Paclitaxel 80 mg/m2 (days 1, 8, 15)
Phase I, Part B and C: LDE225: RP2D established in Part A (days 1-28) and Paclitaxel 80 mg/m2 (days 1, 8, 15)
400, 600 and 800 mg OD
80 mg/m2 (days 1, 8, 15)
Other Name: Taxol
- Dose limiting toxicities (DLTs) of the combination of LDE225 with paclitaxel in patients with advanced solid tumors [ Time Frame: until up to 4 weeks after start of trial therapy ]
- Frequency and severity of adverse events based on the Common Terminology Criteria for Adverse Events V.4.0 (CTCAE). [ Time Frame: expected average 3 months ]
- Objective tumor responses based on RECIST 1.1 criteria. [ Time Frame: expected average 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954355
|Istituto Oncologico della Svizzera Italiana|
|Bellinzona, Switzerland, 6500|
|Chur, Switzerland, 7000|
|Centre Pluridisciplinaire d`Oncologie CHUV|
|Lausanne, Switzerland, 1011|
|Kantonsspital St. Gallen|
|St. Gallen, Switzerland, 9007|
|Study Chair:||Anastasios Stathis, MD||IOSI, Ospedale San Giovanni|
|Study Chair:||Cristiana Sessa, Prof Dr med||IOSI, Ospedale San Giovanni|