Phase
Condition
N/ATreatment
Gemcitabe and Abraxane
G-CSF
FOLFOX-A
Clinical Study ID
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient has been enrolled in the Precision-Panc Master Protocol
- Patient has provided signed information consent for the PRIMUS 001 study
- Age ≥ 16 years
- Histologically-confirmed pancreatic ductal adenocarcinoma and its varients
- Measurable metastatic disease according to RECIST V1.1
- Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12weeks
- Patients must have received no previous chemotherapy or investigational therapy forthe treatment of metastatic disease. Prior treatment with a fluoropyrimidine and/orgemcitabine administered in the adjuvant setting is allowed, provided at least 6months have elapsed since completion of the last dose and no ongoing toxicities arepresent
- Adequate liver/bone marrow function as defined by:
- Neutrophils (ANC) ≥ 1.5 x 109/l
- Platelets ≥ 100 x 109/l
- Haemoglobin ≥ 9.0 g/dL
- White Blood Cells (WBC) ≥ 3 x 109/l
- Total bilirubin ≤ 1.5 x institutional ULN unless bilirubin rise is due toGilbert's syndrome
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN ( <5ULN in the presence of liver metastases)
- Estimated creatinine clearance ≥ 60 mL/min (as calculated by Cockcroft and Gaultor Wright formula or measured by EDTA clearance) 9. Negative serum or urine HumanChorionic Gonadotropin (HCG) test for females with child bearing potential.Postmenopausal women must have been amenorrhoeic for at least 12 months to beconsidered of non-childbearing potential 10. Woman of child bearing potential,and men with female partners of child bearing potential, must agree to useadequate contraceptive measures (see s section 8.1.8.1) for the duration of thestudy and for up to 6 months after the completion of study treatment. 11.Compliant, and can be followed up regularly The following additional inclusion criteria is ONLY required if recommended by theindependent Data Monitoring Committee after interim review of study data (sites will havebeen informed by the Cancer Research UK (CRUK) Clinical Trials Unit (CTU) if this is thecase) 12. Patient must be biomarker positive as fed back after central Precision-Pancdiagnostic testing
Exclusion
Exclusion Criteria:
- Prior treatment with nab-paclitaxel or oxaliplatin
- Prior chemotherapy for metastatic pancreatic cancer
- Known hypersensitivity for any component of any study drug
- Active infection including Herpes Zoster and chickenpox
- Current neuropathy ≥ grade 2
- Uncontrolled brain metastasis
- Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI),unstable angina, stroke, or transient ischemia within previous 6 months
- Uncontrolled serious contraindicated medical condition or illness
- Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- Pregnant or breastfeeding
- History of physical or psychiatric disorder that would prevent informed consent andcompliance with protocol
- Administration of any investigational drug within 28 days or 5 half-lives, whicheveris longer, of receiving the first dose of trial treatment
- Any systemic anti-cancer therapy or major surgery within 28 days of randomisation
- Any minor surgery or radiotherapy within 7 days of randomisation
- Any psychological, familial, sociological or geographical consideration potentiallyhampering compliance with the trial protocol and follow up schedule
- Any patients receiving treatment with brivudin, sorivudin and analogues
- History of another malignancy in the last 5 years (other than treated squamous/basalcell skin cancer, treated early-stage cervical cancer or treated/biochemically-stableorgan-confined prostate cancer)
- Any patient with severe diarrhoea (defined as ≥grade 3 diarrhoea despite maximumsupportive measures and exclusion of underlying infection)
Study Design
Study Description
Connect with a study center
Aberdeen Royal Infirmary
Aberdeen,
United KingdomActive - Recruiting
Northern Ireland Cancer Centre
Belfast,
United KingdomActive - Recruiting
Queen Elizabeth Hospital
Birmingham,
United KingdomActive - Recruiting
Royal Bournemouth Hospital
Bournemouth,
United KingdomActive - Recruiting
Bristol Oncology Centre
Bristol,
United KingdomActive - Recruiting
Addenbrooke's Hospital
Cambridge,
United KingdomActive - Recruiting
Castle Hill Hospital
Cottingham,
United KingdomActive - Recruiting
Ninewells Hospital
Dundee,
United KingdomActive - Recruiting
Western General
Edinburgh,
United KingdomActive - Recruiting
Beatson West of Scotland Cancer Centre
Glasgow,
United KingdomActive - Recruiting
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA
United KingdomActive - Recruiting
Raigmore Hospital
Inverness,
United KingdomActive - Recruiting
St James's University Hospital
Leeds,
United KingdomActive - Recruiting
The Clatterbridge Cancer Centre
Liverpool, CH63 4JY
United KingdomActive - Recruiting
Guy's Hospital
London,
United KingdomActive - Recruiting
Imperial College Healthcare Trust
London,
United KingdomActive - Recruiting
Royal Free London Hospital
London,
United KingdomActive - Recruiting
Royal Marsden Hospital
London,
United KingdomActive - Recruiting
St Bart's Hospital
London,
United KingdomActive - Recruiting
St George's Hospital
London,
United KingdomActive - Recruiting
University College London Hospital
London,
United KingdomActive - Recruiting
The Christie, Manchester
Manchester,
United KingdomActive - Recruiting
Milton Keynes General Hospital
Milton Keynes,
United KingdomActive - Recruiting
Freeman Hospital
Newcastle,
United KingdomActive - Recruiting
Nottingham University Hospital
Nottingham,
United KingdomActive - Recruiting
Churchill Hospital
Oxford,
United KingdomActive - Recruiting
Poole Hospital
Poole,
United KingdomActive - Recruiting
Weston Park
Sheffield,
United KingdomActive - Recruiting
University of Southampton Hospital
Southampton,
United KingdomActive - Recruiting
Singleton Hospital
Swansea,
United KingdomActive - Recruiting
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