A Study LY2228820 for Recurrent Ovarian Cancer

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

In brief

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

Key facts

Study ID

NCT01663857

Run by

Eli Lilly and Company

People needed

118

Starts

2012-07-01

Expected to finish

2018-05-11

Last updated by the study team

2019-09-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St Josephs Hospital and Medical Center — Phoenix, Arizona, United States
• Arizona Oncology Associates, P.C. — Tucson, Arizona, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• H Lee Moffitt Cancer Center — Tampa, Florida, United States
• Franklin Square Hospital Center — Baltimore, Maryland, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• SMO Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Austin, Texas, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Bedford, Texas, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Fort Worth, Texas, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States
• Texas Oncology - The Woodlands — The Woodlands, Texas, United States
• US Oncology — The Woodlands, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Northwest Cancer Specialists PC — Vancouver, Washington, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Adelaide, Australia
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Greenslopes, Australia
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Nedlands, Australia
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Parkville, Australia
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Leuven, Belgium
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Berlin, Germany

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