Epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer MedDRA version: 19.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: LY2228820
Product Code: LY2228820
Pharmaceutical Form: Tablet
Current Sponsor code: LY2228820
Concentration unit: mg milli
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women = 18 years of age Have cytologic or histologic proven epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer Have recurrence of cancer at least 6 months after completion of first-line platinum based therapy Phase 1b - have either measureable or non-measureable disease. Phase 2 - have at least 1 measureable lesion assessable using Response Evaluation Criteria in Solid Tumors Have ECOG performance status = 2 Have discontinued all previous therapies for cancer at least 14 days prior to starting study. Previous radiotherapy must be discontinued at least 21 days prior to start of study Have adequate organ function: Hematology: absolute neutrophil count = 1.5 x 10x9/L, platelets = 100 x 10x9/L, hemoglobin = 8g/dL. Hepatic: billirubin = 1.5 times upper limits of normal, alanin aminotransferase and aspartate aminotransferase = 2.5 times the upper limits of normal. Renal: calculated creatinine clearance = 50ml/min If applicable, have a negative pregnancy test and agree to a reliable method of birth control while receiving investigational product and for 3 months following the last dose of study drug Are able to swallow tablets Have given written informed consent/assent prior to any study specific procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: Are currently enrolled in another clinical trial involved in investigational drug or device Have previously taken LY2228820Have previously been treated with gemcitabine for ovarian, fallopian tube, or primary peritoneal cancer Receiving any cytotoxic or other cancer treatment Have had a major bowel resection that the physician determines would alter oral drug absorption Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) Require concurrent administration of immunosupressive therapy Intermittent corticosteroids used as part of an antiemetic regimen are permitted. Have known central nervous system malignancy or metastasis Have a concurrent or previous malignancy, unless that prior malignancy was treated with definitive therapy at least 5 years previously with no evidence of recurrence. Have serious concomitant systemic disorders incompatible with the study Have received more than one previous chemotherapy regimen for ovarian cancer Have any diagnosis of ovarian borderline tumor Are pregnant or lactating women Are receiving concurrent therapy that the physician determines is immunosuppressive Have known central nervous system malignancy or metastasis Have a concurrent or previous malignancy, unless that prior malignancy was treated with definitive therapy at least 5 years previously with no evidence of recurrence. Have a serious systemic disorder that the physician determines is incompatible with the study Have received more than one previous chemotherapy regimen for ovarian cancer Have tumor of borderline malignancy Are pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b - to determine the recommended Phase 2 dose of LY2228820 that can be safely administered with gemcitabine and carboplatin Phase 2 - to compare the progression-free survival in patients treated with LY2228820 plus gemcitabine and carboplatin versus placebo plus gemcitabine and carboplatin ; Secondary Objective: 1. Change in tumor size, CA 125, overall response rate, overall survival 2. Safety and tolerability of the combination of LY2228820 with gemcitabine and carboplatin 3. Pharmacokinetics (PK) of LY2228820 and evaluation for effect of LY2228820 on the PK of gemcitabine, its metabolite (dFdU), and carboplatin 4. Biomarkers related to the p38 MAPK pathway activity and the pathogenesis of ovarian cancer 5. Patient-reported outcomes ; Primary end point(s): Phase 1b – Safety and dose Phase 2 – Progression free survival. ; Timepoint(s) of evaluation of this end point: Phase 1b - after all evaluable patients have received at least 1 cycle of study treatment Phase 2 - after 79 PFS events have occurred | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in tumor size, CA125, overall response rate, overall survival Safety and tolerability of the combination of LY2228820, gemcitabine, and carboplatin Pharmacokinetics of LY2228820, gemcitabine and its metabolite (dFdU), and carboplatin Biomarkers related to p38 MAPK pathway activity and the pathogenesis of ovarian cancer Patient-reported outcomes ; Timepoint(s) of evaluation of this end point: Phase 1b: N/A Phase II: After 30 patients in have received 1 cycle of study therapy, after 60 patients have received at least 2 cycles of therapy, and final analysis is 2 years after completion of enrollment. | — |
Countries
Australia, Belgium, Germany, India, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed