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A Study of LY2228820 for Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01663857
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

August 8, 2012
August 13, 2012
July 18, 2018
July 2012
May 25, 2017   (Final data collection date for primary outcome measure)
  • Phase 1b: Recommended Phase 2 Dose of LY2228820 [ Time Frame: Cycle 1 (21 Days) ]
  • Phase 2: Progression-Free Survival [ Time Frame: Baseline to Date of Disease Progression or Death from any cause (estimated up to 3 years) ]
Same as current
Complete list of historical versions of study NCT01663857 on ClinicalTrials.gov Archive Site
  • Phase 2: Percentage of Participants who Achieve Complete Response or Partial Response (Overall Response Rate) [ Time Frame: Baseline to Disease Progression ( estimated up to 3 years) ]
  • Overall Survival [ Time Frame: Baseline to Date of Death from any cause (estimated up to 5 years) ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve of LY2228820 [ Time Frame: Phase 1b Cycles 1-3 Days 1, 10 and 11 Predose up to 12 hours Postdose, Cycle 7 Day 3 Predose up to 8 hours Postdose; Phase 2 Cycles 1-2 Days 1, 3, 10 and 11 Predose up to 12 hours Postdose, Cycle 7 Day 3 Predose up to 8 hours Postdose ]
  • Phase 2: Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) score [ Time Frame: Baseline, Study Completion (estimated up to 3 years) ]
Same as current
Not Provided
Not Provided
 
A Study of LY2228820 for Recurrent Ovarian Cancer
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Drug: LY2228820
    Administered Orally
  • Drug: Carboplatin
    Administered IV
  • Drug: Placebo
    Administered Orally
  • Drug: Gemcitabine
    Administered IV
    Other Names:
    • Gemzar
    • LY188011
  • Experimental: Phase 1b 200 mg LY2228820

    Induction: Cycles 1-6 (21 day cycles)- 200 milligrams (mg) LY2228820 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 (mg-min/ml) administered IV over 30 minutes on day 3.

    Maintenance: Cycles 7+ (28 day cycles)- 300 mg LY2228820 administered orally every 12 hours on days 1-14.

    Interventions:
    • Drug: LY2228820
    • Drug: Carboplatin
    • Drug: Gemcitabine
  • Experimental: Phase 1b 300 mg LY2228820

    Induction: Cycles 1-6 (21 day cycles)- 300 mg LY2228820 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 AUC 4 administered IV over 30 minutes on day 3.

    Maintenance: Cycles 7+ (28 day cycles)- 300 mg LY2228820 administered orally every 12 hours on days 1-14.

    Interventions:
    • Drug: LY2228820
    • Drug: Carboplatin
    • Drug: Gemcitabine
  • Experimental: Phase 2 dose LY2228820

    Induction: Cycles 1-6 (21 day cycles)- Recommended Phase 2 dose of LY2228820 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 AUC 4 administered IV over 30 minutes on day 3.

    Maintenance: Cycles 7+ (28 day cycles)- 300 mg LY2228820 administered orally every 12 hours on days 1-14.

    Interventions:
    • Drug: LY2228820
    • Drug: Carboplatin
    • Drug: Gemcitabine
  • Placebo Comparator: Phase 2 Placebo

    Induction: 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 AUC 4 administered IV over 30 minutes on day 3.

    Maintenance: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind.

    Interventions:
    • Drug: Carboplatin
    • Drug: Placebo
    • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
116
May 11, 2018
May 25, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Germany,   United States
India
 
NCT01663857
12517
I1D-MC-JIAE ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time *UTC/GMT-5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP