A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.
Name: LY2228820
Description: Administered OrallyType: DrugPhase 1b (Cohort 1) LY2228820 200 milligrams (mg) Phase 1b (Cohort 2) LY2228820 300 mg Phase 2 (Arm A) LY2228820 200 mg
Name: Carboplatin
Description: Administered IVType: DrugPhase 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
Name: Placebo
Description: Administered OrallyType: DrugPhase 2 (Arm B) Placebo
Name: Gemcitabine
Description: Administered IVType: DrugPhase 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
Description: Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).
Measure: Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD]) Time: Cycle 1 (21 Days)Description: PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measure: Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin Time: Randomization to Date of Disease Progression or Death from any cause (up to 3 years)Description: Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Measure: Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate) Time: Baseline to Disease Progression (up to 3 years)Description: Data presented are the median overall survival in months for participants in the Phase 2 treatment arms.
Measure: Phase 2: Overall Survival Time: Baseline to Date of Death from any cause (up to 5 years)Description: PK parameters after administration of LY2228820 for both Phase 1b and Phase 2.
Measure: Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820 Time: Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPDDescription: The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = "not at all" and 4 = "very much." Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life.
Measure: Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score Time: Baseline, Study Completion (up to 3 years)Allocation: Randomized
Parallel Assignment
There is one SNP
The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).. Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin. --- Q12H ---