A Study in a Type of Pancreatic Cancer that has Spread Beyond the Pancreas

Phase 1

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
MedDRA version: 19.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-002218-36-FR

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 256

Inclusion Criteria

[1] have cytologically or histologically confirmed diagnosis of ductal
adenocarcinoma of the pancreas.
[2] have metastatic disease with documented disease progression following
previous treatment with at least one, but no more than 2 prior therapies, with
one of the prior therapies having been either gemcitabine-based or
fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for
localized resectable or unresectable PDAC each count as a line of therapy if
multiagent chemotherapy regimens were administered (and neoadjuvant
regimen was different than adjuvant regimen) and if the patient progressed
with metastatic disease while taking or within 6 months of completion of
(neo)adjuvant therapy.
[3] have the presence of measurable disease as defined by Response Evaluation
Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
[4] have a performance status (PS) of 0 to 1 on the ECOG scale
[5] is a patient for whom treatment with monotherapy chemotherapy such as
gemcitabine or capecitabine is a reasonable choice.
have discontinued all previous treatments for cancer (including cytotoxic
chemotherapy, molecularly targeted therapy, radiotherapy, immunotherapy,
and investigational therapy) for at least 14 days prior to receiving the initial
dose of study treatment, and recovered from the acute effects of therapy
(treatment-related toxicity resolved to baseline) except for residual alopecia or
peripheral neuropathy.
[7} have adequate organ functions
[8] are at least 18 years old at the time of screening or of an age acceptable
according to local regulations, whichever is older.
[9] men must be sterile or agree to use an effective method of contraception or a
highly effective method of contraception during the study and for at least
6 months following the last dose of study drug.
[10] women of child-bearing potential must:
a. have a negative serum pregnancy test within 7 days prior to study
treatment initiation, and
b. agree to use a highly effective method of contraception during the study
and for at least 6 months following the last dose of study drug.
[11] have given written informed consent prior to any study-specific procedures.
[12] are able to swallow capsules and tablets.
[13] are reliable and willing to make themselves available for the duration of the
study and are willing to follow study 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[14] have a serious concomitant systemic disorder or preexisting condition (for
example, active infection including human immunodeficiency virus, history of
major surgical resection involving the stomach or small bowel, or preexisting
Crohn’s disease or ulcerative colitis) that, in the opinion of the investigator,
would compromise the patient’s safety or ability to adhere to the protocol.
[15] have severe cardiac disease:
? Myocardial infarction within 6 months prior to study screening, unstable angina
pectoris, New York Heart Association Class III/IV congestive heart failure, or
uncontrolled hypertension.
? Documented major electrocardiogram (ECG) abnormalities, at the investigator’s
discretion (for example, symptomatic or sustained atrial or ventricular
arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks,
ventricular hypertrophy, or recent myocardial infarction), not responding to
medical treatments or not clinically stable for at least 6 months prior to study
screening.
? Major cardiac abnormalities documented by echocardiography (ECHO) with
Doppler that are not clinically stable for at least 6 months prior to study screening
(for example, severe heart valve function defect and/or left ventricular ejection
fraction [LVEF] <50%, evaluation based on the institutional lower limit of
normal). For additional details, refer to Echocardiography Protocol (Appendix 6).
[16] Predisposing conditions that are consistent with development of aneurysms of
the ascending aorta or aortic stress (for example, family history of aneurysms,
Marfan-Syndrome, bicuspid aortic valve, or evidence of damage to the large
vessels of the heart documented by Computed Tomography [CT] scan or
magnetic resonance imaging [MRI] with contrast).
[17] have insulin-dependent diabetes mellitus. Patients with type 2 diabetes
mellitus are eligible if adequate control of blood glucose level is obtained by
oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.
[18] have symptomatic central nervous system metastasis. Screening of asymptomatic patients is not required for enrollment.Screening is not required for enrollment.
[19] have a history of any other cancer (except nonmelanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission with no therapy
for a minimum of 2 years.
[20] have had major surgery within 7 days prior to initiation of study drug to allow for
postoperative healing of the surgical wound and site(s).
[21] are currently enrolled in a clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study. If a patient is currently enrolled in a clinical trial
involving nonappr

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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