Brief Title
A Study LY2228820 for Recurrent Ovarian Cancer
Official Title
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
Brief Summary
A study for women with ovarian cancer that has returned at least 6 months after
platinum-based chemotherapy.
Detailed 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])
Secondary Outcome
Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)
Condition
Epithelial Ovarian Cancer
Intervention
LY2228820
Study Arms / Comparison Groups
Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
118
Start Date
July 2012
Completion Date
May 11, 2018
Primary Completion Date
May 25, 2017
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time *UTC/GMT-5 hours, EST), ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01663857
Organization ID
12517
Secondary IDs
I1D-MC-JIAE
Responsible Party
Sponsor
Study Sponsor
Eli Lilly and Company
Study Sponsor
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time *UTC/GMT-5 hours, EST), Study Director, Eli Lilly and Company
Verification Date
August 2019