Pancreas adenocarcinoma
Conditions
Interventions
All participating patients in this trial will receive gemcitabine intravenously
over
approximately 30 minutes (maximum 60 minutes) at a dose of 1000 mg/m2 on Days
1, 8,and 15 followed by a week of r
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV) and not amenable to resection with curative intent. Patients with previous radical surgery for pancreas cancer are eligible after progression is documented. If they received adjuvant chemotherapy or chemoradiotherapy with gemcitabine, they can be enrolled if the treatment was completed 6 months before or longer.;[3] Have measurable disease or non-measurable disease, defined according to RECIST (Protocol Attachment JMMC.5).;[4] Males or females at least 18 years of age.;[5] Have given written informed consent prior to any study-specific procedures.;[6] Have adequate organ function including: * Hematologic: Absolute neutrophil count (ANC) *1.5 x 109/L platelets *100 x 109/L, and hemoglobin *9 g/dL. * Hepatic: Bilirubin *1.5 times upper limits of normal (ULN), aspartate transaminase (AST)
Exclusion criteria
Exclusion criteria: -Are currently enrolled in, or discontinued within the last 28 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. -Have serious preexisting medical conditions or serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris or uncontrolled diabetes mellitus). -Have symptomatic central nervous system malignancy or metastasis (screening not required). -Have current active infection that would, in the opinion of the investigator, compromise the patient*s ability to tolerate therapy. -Females who are pregnant or lactating. -Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Testing is not required unless circumstances warrant confirmation. -Endocrine pancreatic tumors or ampullary cancer. -Have previously completed or withdrawn from this study or any other study investigating LY2603618 or any other Chk1 inhibitor. -Have known allergy to gemcitabine or LY2603618 or any ingredient of gemcitabine or LY2603618. -Has an abnormal ECG result that would put the patient at unnecessary risk in the opinion of the investigator. -Have conduction abnormalities, ischemic changes such as prior Qwave myocardial infarction and/or marked ischemic ST and T wave, and arrhythmias such as persistent or paroxysmal ventricular or supraventricular arrhythmias, including atrial fibrillation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) is the primary outcome of interest. Pharmacokinetic (PK) analyses will be conducted on patients who have received at least 1 dose of the study drug and have had samples collected. All patients who receive at least 1 dose of study drug will be evaluated for safety and toxicity. The primary safety outcome will be to compare the incidence of AEs between the 2 treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary efficacy parameters will be summarized for each treatment group: * Progression-free survival (PFS) * Overall Response Rate (ORR) * Clinical benefit rate | — |
Countries
Netherlands
Outcome results
None listed