A study comparing gemcitibine and carboplatin with or without LY2228820 for women with ovarian cancer

Phase 1

Active, not recruiting

• Conditions: Epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; MedDRA version: 18.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005197-40-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-05
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 120

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 aminotransferasa = 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

Are currently enrolled in another clinical trial involved in investigational drug or device
Have previously taken LY2228820
Have 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified