West Cancer Center

OVARIAN: Recurrent; Platinum-Sensitive; "I1D-MC-JIAE"

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

Title

Eli Lilly I1D-MC-JIAE

Study Title

Site Link

NCT01663857

Malignancy

Ovarian, fallopian tube, primary peritoneal cancer

Stage

Stage 4

Disease Setting

Recurrent Disease

Line Of Therapy

2nd Line (post platinum)

Investigational Agent

LY2228820

Drug Class

p38 MAP kinase inhibitor

Todd Tillmanns, MD

Sponsor

Eli Lilly and Company

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/study/NCT01663857

Key Eligibility Criteria Details

Treated for one course of platinum-based therapy
Recurrence at least 6 months after completing platinum therapy
ECOG PS 0-2
No prior tx with gemcitabine
No CNS involvement_

Objective

Primary- PFS; Secondary- ORR, OS, QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Ovarian, Primary peritoneal, or fallopian tube cancer

Dosing Frequency

Recommended dose of LY2228820 Day 1-10 of 21 day cycle q12 hours PO

Control Agents

Gemcitabine and Carboplatin

Study Protocol

Randomized

Yes