NCT01663857

A Study LY2228820 for Recurrent Ovarian Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38 MAPK Inhibitor, Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin for Women With Platinum-Sensitive Ovarian Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.

Detailed description

Phase 1b is unblinded and will have a small number of participants that will take LY2228820 plus gemcitabine and carboplatin to test the safety of the combination and determine a recommended dose for the Phase 2 portion. Phase 2 will be blinded and all study participants will receive carboplatin and gemcitabine. Participants of one group will receive LY2228820, and the other group will receive placebo. If the participant achieves at least stable disease, there is a maintenance phase following the first 6 cycles. The participant will take either LY2228820 or placebo. The participant will continue therapy until disease progression or other discontinuation criteria are fulfilled.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	LY2228820	Administered Orally
DRUG	Carboplatin	Administered IV
DRUG	Placebo	Administered Orally
DRUG	Gemcitabine	Administered IV

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-05-25
• Completion: 2018-05-11
• First posted: 2012-08-13
• Last updated: 2019-09-11
• Results posted: 2019-05-29

Locations

30 sites across 4 countries: United States, Australia, Belgium, Germany