Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02195973|
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Ovarian Cancer||Drug: LDE225||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IB Trial of LDE225 and Weekly Paclitaxel in Recurrent Platinum Resistant Ovarian Cancer|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 10, 2016|
|Actual Study Completion Date :||September 30, 2017|
Experimental: Paclitaxel + LDE225
Patients will receive intravenous paclitaxel on days 1, 8, and 15 every 28 days (3 weeks on followed by one week off). This constitutes one cycle. in addition to the paclitaxel oral LDE225 will be taken daily. Dosages of each drug will vary according to the study cohort and phase. The study consists of six cycles of treatment followed by clinic visits every 2-3 months for up to two years.
After six cycles of weekly paclitaxel and LDE225, patients with a clinically beneficial response may be continued on weekly paclitaxel alone until disease progression.
- Safety of weekly paclitaxel + LDE225 treatment [ Time Frame: up to 2 years ]Safety of weekly paclitaxel and LDE225 treatment in patients with recurrent, platinum-resistant ovarian adenocarcinoma will be monitored by physical exams, review of adverse events, and laboratory studies.
- Assessment of toxicities [ Time Frame: up to 2 years ]Assessment of toxicity will be performed using the National Cancer Institute Common Toxicity Criteria version 4.03.
- Optimal dose of LDE225 with paclitaxel [ Time Frame: 6 months ]The maximum tolerated dose and dose-limiting toxicities of weekly paclitaxel and daily LDE225 will be determined from laboratory tests on blood collected one to two times each cycle.
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): NCT02195973
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Charles A Leath, III, MD, MSPH||University of Alabama at Birmingham|