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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT01663857

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 29 Locations for this study

See Locations Near You

St Josephs Hospital and Medical Center
Phoenix Arizona, 85013, United States
Arizona Oncology Associates, P.C.
Tucson Arizona, 85710, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
H Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
Barnes Jewish Hospital
Saint Louis Missouri, 63110, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
SMO Sarah Cannon Research Inst.
Nashville Tennessee, 37203, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Austin Texas, 78731, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Bedford Texas, 76022, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Fort Worth Texas, 76104, United States
Cancer Care Centers of South Texas
San Antonio Texas, 78229, United States
Texas Oncology - The Woodlands
The Woodlands Texas, 77380, United States
US Oncology
The Woodlands Texas, 77380, United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Northwest Cancer Specialists PC
Vancouver Washington, 98684, 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 , 5000, 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 , 4120, 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 , 6009, 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 , 3053, 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 , 3000, 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 , 10117, Germany
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.
Essen , 45122, Germany
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.
Essen , 45136, Germany
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.
Greifswald , 17489, Germany
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.
Mainz , 55131, Germany
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.
München , 81675, Germany

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT01663857

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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