A study of LY2603618 with gemcitabine in patients with pancreaticcancer

Conditions: Phase II: Patients with pancreatic cancer.
MedDRA version: 14.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-006209-17-IT

Lead Sponsor: ELI LILLY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 99

Inclusion Criteria

[2] Phase 2 portion: 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. [3] For Phase 2 only: Have measurable disease or non-measurable disease, defined according to RECIST [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(hematologic, hepatic, renal) [7] Have a performance status of =2 on the ECOG scale [8] For Phase 1: Patients enrolling in Phase 1 portion of study may have prior chemotherapy, radiotherapy, cancer-related hormone therapy, or other investigational therapy as treatment. There is no limit in the number of previous lines of therapy. For Phase 2: Patients may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer. [9] Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. [10] Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physicians deems it safe to become pregnant or father a child. [11] Females with child bearing potential must have had a negative urine pregnancy test =7 days prior to the first dose of study drug. [13] Prior radiation therapy for treatment of cancer other than pancreatic is allowed to <25% of the bone marrow, and patients must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. [14] Baseline ECG QTc interval corrected by Bazett's method (should be <450 msec for males and <470 msec for females.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

[15] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [16] 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 [17] Have symptomatic central nervous system malignancy or metastasis [18] Have current active infection that would, in the opinion of the investigator, compromise the patient's ability to tolerate therapy. [19] Females who are pregnant or lactating. [20] Have known positive test results in human immunodeficiency virus XML File Identifier: RbejZKBN5vo9DKFIBouWRDUVWFY= Page 21/32 (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) [21] Phase 2 only: Endocrine pancreatic tumors or ampullary cancer. [22] Phase 1: Patients with acute or chronic leukemia or with any other disease likely to have a significant bone marrow infiltration [23] Have previously completed or withdrawn from this study or any other study investigating LY2603618 or any other Chk-1 inhibitor. [24] Have known allergy to gemcitabine or LY2603618 or any ingredient of gemcitabine or LY2603618. [25] Has an abnormal ECG result that would put the patient at unnecessary risk in the opinion of the investigator. [26] 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase 2; Primary objective is to determine if overall survival in patients with Stage II-IV unresectable pancreatic cancer administered LY2603618 plus gemcitabine exceeds gemcitabine monotherapy;Secondary Objective: Phase II: To characterize further the safety and toxicity profile of LY2603618 when administered after gemcitabine and to compare it to the safety profile of gemcitabine monotherapy, stimate other time-to-event variables, explore the percentage change in tumor size at 8 weeks, document response rate per RECIST, evaluate the PKs of gemcitabine, dFdU and LY2603618 in combination, assess biomarker responses associated with LY2603618 and gemcitabine combination, perform an exploratory assessment of QTc.;Primary end point(s): Phase II: OS in patients with stage II-IV unresectable pancreatic cancer who received LY2603618 and gemcitabine combination arm compared to OS on the gemcitabine only.;Timepoint(s) of evaluation of this end point: 9 months after 99th patient enrolled

Secondary Outcome Measures