NCT02195973

Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

Phase IB Trial of LDE225 and Weekly Paclitaxel in Recurrent Platinum Resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial effects when combined with paclitaxel in women with platinum resistant ovarian cancer. Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).

Detailed description

Ovarian cancer remains the deadliest gynecologic cancer with a fairly low long-term cure rate. LDE225 is a new type of drug that inhibits or blocks a pathway responsible for cancer cell growth. LDE225 is an investigational drug that has been used either solely or in combination with chemotherapy in other types of cancer but not in ovarian cancer. Research evidence suggests that by combining LDE225 and paclitaxel together, ovarian cancer cells may become more responsive to treatment.

Conditions

• Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	LDE225	After six cycles of weekly paclitaxel and LDE225, patients with a clinically beneficial response may be continued on weekly paclitaxel alone until disease progression.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-12-10
• Completion: 2017-09-30
• First posted: 2014-07-21
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States