A Study LY2228820 for Recurrent Ovarian Cancer
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer
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
Sites / Locations
- St Josephs Hospital and Medical Center
- Arizona Oncology Associates, P.C.
- Sarasota Memorial Hospital
- H Lee Moffitt Cancer Center
- Franklin Square Hospital Center
- Barnes Jewish Hospital
- Rutgers Cancer Institute of New Jersey
- University of Oklahoma Health Sciences Center
- Thomas Jefferson University
- SMO Sarah Cannon Research Inst.
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- Cancer Care Centers of South Texas
- Texas Oncology - The Woodlands
- US Oncology
- Tyler Cancer Center
- Northwest Cancer Specialists PC
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)
Phase 1b (Cohort 2) LY2228820 300 mg
Phase 2 (Arm A) LY2228820 200 mg
Phase 2 (Arm B) Placebo
Cohort 1: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 milligrams per square meter (mg/m^2) administered intravenously (IV) over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.. Cohort 1: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.
Cohort 2: Cycles 1-6 (21 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Cohort 2: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.
Arm A: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm A: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.
Arm B: Cycles 1-6 (21 day cycles)- Placebo administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm B: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind.