Ovarian Cancer Clinical Trial
A Study LY2228820 for Recurrent Ovarian Cancer
Summary
A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.
Full 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.
Eligibility Criteria
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
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There are 29 Locations for this study
Phoenix Arizona, 85013, United States
Tucson Arizona, 85710, United States
Sarasota Florida, 34239, United States
Tampa Florida, 33612, United States
Baltimore Maryland, 21237, United States
Saint Louis Missouri, 63110, United States
New Brunswick New Jersey, 08901, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78731, United States
Bedford Texas, 76022, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77380, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Vancouver Washington, 98684, United States
Adelaide , 5000, Australia
Greenslopes , 4120, Australia
Nedlands , 6009, Australia
Parkville , 3053, Australia
Leuven , 3000, Belgium
Berlin , 10117, Germany
Essen , 45122, Germany
Essen , 45136, Germany
Greifswald , 17489, Germany
Mainz , 55131, Germany
München , 81675, Germany
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