A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 plus Cisplatin to Gemcitabine plus Cisplatin in Patients w/Previously Untreated Locally Advanced or Metastatic Biliary Cancer
A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 plus Cisplatin to Gemcitabine plus Cisplatin in Patients with Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer
Clinical Trial Information
Trial Contact: De Leon, Ma Theresa
Trial Phone: 321.841.8284
IRB No: W19.238.08
Protocol Abbrev: NuTide 121
Principal Investigator: Omar R. Kayaleh, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: NuTide:121
Treatment: ARM A: NUC-1031 plus Cisplatin ARM B: Gemcitabine plus Cisplatin
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04163900
Overall survival (OS)
Objective response rate (ORR) based on blinded independent central review (BICR) in patients with measurable disease at baseline.
Written informed consent and authorization to use and disclose health information.
Ability to comprehend and willingness to comply with the requirements of this protocol, including the QoL questionnaires.
Female or male patients aged ≥18 years.
Histologically- or cytologically-confirmed adenocarcinoma of the biliary tract (including gallbladder, intra and extra-hepatic biliary ducts and ampullary cancers) that is locally advanced, unresectable or metastatic. Patients with measurable (as per RECIST v1.1 criteria) or non-measurable disease are permitted.
Life expectancy ≥16 weeks.
ECOG performance status 0 or 1.
Adequate biliary drainage with no evidence of ongoing infection. If applicable, treatable and clinically-relevant biliary duct obstruction has been relieved by internal endoscopic drainage/stenting at least 2 weeks previously or by palliative bypass surgery or percutaneous drainage prior to study entry, and the patient has no active or suspected uncontrolled infection. Patients fitted with a biliary stent should be clinically stable and free of signs of infection for ≥2 weeks prior to study entry. Patients with improving biliary function who meet all other inclusion criteria may be re-tested during the screening window.
Adequate bone marrow, hepatic, and renal function, as evidenced by:
• Absolute neutrophil count (ANC) ≥1,500/μL without colony-stimulating factor support
• Platelet count ≥100,000/μL
• Hemoglobin ≥10 g/dL without need for haematopoietic growth factor or transfusion support in prior 2 weeks
• Total bilirubin <2 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome. Consistent with inclusion criterion 7, patients whose whole bilirubin and biliary function is recovering may be re-tested during the screening period.
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <5 × ULN
• Serum creatinine ≤1.5 × ULN or creatinine clearance ≥45 mL/min actual or calculated by the Cockcroft-Gault method
• International normalised ratio (INR) <1.5 and partial thromboplastin time (PTT) <1.5 × ULN; does not apply to patients on an anti-coagulant with stable dose 28 days prior to first dose.
QTc interval <450 msec (males) or <470 msec (females), in the absence of bundle branch block. In the presence of bundle branch block with consequent QTc prolongation, patients may be enrolled based on a careful risk-benefit assessment.
Human Immunodeficiency Virus-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome-related outcomes may be included in this study.
Female patients of child-bearing potential (i.e., all women except those who are post-menopausal for ≥1 year or who have a history of hysterectomy or surgical sterilization) must have a negative pregnancy test within 3 days prior to the first study drug administration. All patients of child-bearing potential must agree to practice true abstinence or to use two highly effective forms of contraception, one of which must be a barrier method of contraception, from the time of screening until 6 months after the last dose of study medication.
Male patients with a female partner must either have had a successful vasectomy or they and their female partner meet the criteria above (not of childbearing potential or practicing highly effective contraceptive methods).