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Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

NCT02195973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-09

No results posted yet for this study

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).

Conditions

  • Recurrent Ovarian Cancer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Charles A Leath, III, MD, MSPH · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-10
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195973 on ClinicalTrials.gov