A Study of LY2228820 for Recurrent Ovarian Cancer



Status:Completed
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:July 2012
End Date:May 11, 2018

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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

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
We found this trial at
20
sites
Tucson, Arizona 85745
Principal Investigator: Joseph Buscema
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Adelaide,
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Austin, Texas 78731
Principal Investigator: Michael Teneriello
Phone: 512-421-4183
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Baltimore, Maryland 21237
Principal Investigator: Pallavi Kumar
Phone: 443-777-7364
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Bedford, Texas 76022
Principal Investigator: Mark Messing
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Bedford, TX
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Dallas, Texas 75246
Principal Investigator: Colin Koon
Phone: 214-370-1000
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1450 8th Avenue
Fort Worth, Texas 76104
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Nashville, Tennessee 37203
Principal Investigator: Sarah Cannon Research Inst.
Phone: 615-329-7615
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New Brunswick, New Jersey 08903
Principal Investigator: Darlene Gibbon
Phone: 732-235-7258
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New Brunswick, NJ
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Kathleen Moore
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Russell Schilder
Phone: 215-503-3057
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: BRADLEY MONK
Phone: 602-406-7730
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Saint Louis, Missouri 63110
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Principal Investigator: Antonio Santillan-Gomez
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Principal Investigator: James Fiorica
Phone: 941-917-4797
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Tampa, Florida 33612
Principal Investigator: Robert Wenham
Phone: 813-745-3522
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The Woodlands, Texas 77380
Principal Investigator: Christine Lee
Phone: 281-296-0365
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The Woodlands, Texas 77380
Principal Investigator: SMO US Oncology
Phone: 281-863-1000
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Tyler, Texas 75702
Principal Investigator: Donald Richards
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Vancouver, Washington 98684
Principal Investigator: Rodney Rushing
Phone: 360-449-6522
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