A Study LY2228820 for Recurrent Ovarian Cancer

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

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

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