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

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

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.

Inclusion Criteria:

• Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
• Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment
• Are able to swallow tablets
• Have given written informed consent prior to any study procedures
• Have adequate blood counts, hepatic and renal function
• Have performance status equal to or less than 2 on Eastern Cooperative Oncology Group (ECOG) scale
• Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug

Exclusion Criteria:

• Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer
• Are currently enrolled or discontinued less than 14 days from another clinical trial
• Have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected.
• Must not be pregnant or breastfeeding.
• Have malignancy or metastasis of the central nervous system
• Have borderline malignancy