A trial looking at two chemotherapy treatments given prior to surgery for pancreatic cancer, looking at biomarker development

Phase 1

• Conditions: Pancreatic cancer; MedDRA version: 20.0 Level: LLT Classification code 10033608 Term: Pancreatic cancer resectable System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004156-29-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 242

Inclusion Criteria

1 Patient has been enrolled in the Precision-Panc Master Protocol and their tissue
has been deemed suitable for NGS analysis (a Precision-Panc Master Protocol
identifier will be required at the time of study enrolment)
2 Signed informed consent given for PRIMUS 002 study
3 Age = 16 years
4 Resectable or borderline resectable pancreatic cancer as defined by NCCN criteria
following discussion at the Multi Disciplinary Team (MDT)
5 Measurable Disease as per RECIST 1.1
6 Histological or cytologically proven pancreatic ductal adenocarcinoma (including
variants)
7 Able to undergo biliary drainage using a covered or partially covered
self-expanding metal stent if jaundiced
8 ECOG performance status 0 and 1
9 Adequate liver/bone marrow function as defined by:
a. Neutrophils (ANC) = 1.5 x 109/l
b. Platelets = 100 x 109/l
c. Haemoglobin = 9.0g/dL
d. White Blood Cells (WBC) = 3 x 109/l
e. Total bilirubin = 1.5 x institutional upper limit of normal (ULN) unless
bilirubin rise is due to Gilbert’s syndrome
f. Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 2.5 x
ULN (or <5 x ULN in the presence of liver metastases)
g. Estimated creatinine clearance = 60 mL/min (as calculated by Cockcroft
and Gault or Wright formula or measured by EDTA clearance)
10 Negative serum Human Chorionic Gonadotropin (HCG) test for females with child
bearing potential. Postmenopausal women must have been amenorrhoeic for at least
12 months to be considered of non-childbearing potential
11 Woman of child bearing potential, and men with female partners of child bearing
potential, must agree to use adequate contraceptive measures (see section 8.1.8.1)
for the duration of the study and for up to 6 months after the completion of study
treatment.
12 Able to comply with protocol requirements and deemed fit for surgical resection,
chemotherapy and CRT
Are the trial subjects under 18? yes
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 169
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 73

Exclusion Criteria

1 Distant metastatic disease
2 History of previous or concurrent malignancy diagnosis (except curatively treated
basal cell carcinoma of skin or carcinoma in situ of cervix)
3 Prior chemotherapy or CRT for pancreatic cancer
4 Known hypersensitivity for any component of any study drug
5 Active infection including Herpes Zoster and chickenpox
6 Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia
(MI), unstable angina, stroke, or transient ischemia within previous 6 months.
7 Serious medical or psychological condition precluding neo-adjuvant treatment and
surgical resection
8 New York Heart Association Classification Grade III or IV
9 Body Mass Index (BMI) >35
10 Liver Cirrhosis (except for Child-Pugh A)
11 CPET results outwith appropriate level for surgical resection. AT < 10 or METS < 5 12 Major surgery within 28 days prior to trial entry
13 Any patients receiving treatment with brivudin, sorivudin and analogues
14 Any patient with severe diarrhoea (defined as =grade 3 diarrhoea despite maximum
supportive measures and exclusion of underlying infection)
15 Patients with known malabsorption
16 Patients with known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency.
17 Grade = 2 peripheral neuropathy
18 Administration of any investigational drug within 28 days or 5 half-lives,
whichever is longer, prior to receiving the first dose of trial treatment

Study & Design

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