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

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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

The primary objective of the Phase 1b portion of this study is to determine the recommended Phase 2 dose of LY2228820 that can be safely administered in combination with gemcitabine and carboplatin.
The primary objective of the Phase 2 portion of this study is to compare the progression-free survival in patients treated with LY2228820 plus gemcitabine and carboplatin versus placebo plus gemcitabine and carboplatin.

The secondary objectives of the study are to evaluate:
1. Change in tumor size, CA125 (serum biomarker for ovarian cancer), overall response rate, and overall survival (OS)
2. Safety and tolerability of the combination: LY2228820 plus gemcitabine and carboplatin
3. Pharmacokinetics (PK) of LY2228820 and evaluation for effect of LY2228820 on the PK of gemcitabine, its metabolite (dFdU), and carboplatin
4. Biomarkers related to p38 MAPK pathway activity and the pathogenesis of ovarian cancer
5. Patient-reported outcomes for patients enrolled in the Phase 2 portion of the study

Protocol Number101201
Principal InvestigatorDarlene Gibbon
PhasePhase I/II
ScopeNational
Applicable Disease SitesOvary
Therapies InvolvedTherapy (NOS)
Chemotherapy multiple agents systemic
Drugs InvolvedLY2228820
CARBOPLATIN
PLACEBO
GEMCITABINE
Participating InstitutionsRobert Wood Johnson University Hospital in New Brunswick
Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.