A study of LY2603618 with gemcitabine in patients with pancreatic cancer

Phase 1

• Conditions: Phase I: Patients with solid malignancy unlikely to benefit from approved therapies.Phase II: Patients with pancreatic cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006209-17-SK
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-02
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

[1] Phase 1 portion: Have histological or cytological evidence of a
diagnosis of cancer that is advanced and/or metastatic disease; that is
refractory to standard therapy and/or therapies known to provide
clinical benefit or for which no standard therapy exists; and/or in
which gemcitabine therapy at the proposed doses and schedule would
be considered appropriate treatment for the metastatic disease.

[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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 149
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
(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