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Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract 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

NCT04163900•NuCana plc

View on ClinicalTrials.gov

Summary

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: * The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care * The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and authorization to use and disclose health information.
•2. Ability to comprehend and willingness to comply with the requirements of this protocol, including the QoL questionnaires.
•3. Female or male patients aged ≥18 years.
•4. 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 (AJCC edition 8, 2018). Patients with measurable (as per RECIST v1.1 criteria) or non-measurable disease are permitted.
•5. Life expectancy ≥16 weeks.
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•8. 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
•* Haemoglobin ≥9 g/dL without need for haematopoietic growth factor or transfusion support in prior 2 weeks
+18 more criteria

Exclusion Criteria

•1. Combined or mixed hepatocellular/cholangiocarcinoma.
•2. Prior systemic therapy for advanced or metastatic biliary tract cancer. However, prior chemotherapy in the adjuvant setting or low-dose chemotherapy given in conjunction with radiotherapy in the adjuvant setting and completed at least 6 months prior to enrolment is permitted. The following prior interventions are allowed provided the patient has fully recovered:
•* Surgery: non-curative resection with macroscopic residual disease or palliative bypass surgery. Patients who have previously undergone curative surgery must now have evidence of non-resectable disease requiring systemic chemotherapy.
•* Radiotherapy: prior radiotherapy (with or without radio-sensitizing low-dose chemotherapy) for localized disease and there is now clear evidence of disease progression requiring systemic chemotherapy.
•* Photodynamic therapy: prior photodynamic therapy for localized disease with no evidence of metastatic disease or for localized disease to relieve biliary obstruction in the presence of metastatic disease provided there is now clear evidence of disease progression requiring systemic chemotherapy.
•* Palliative radiotherapy: palliative radiotherapy provided that all adverse events have resolved and the patient has measurable disease outside the field of radiation.
•3. Prior treatment with or known hypersensitivity to NUC-1031, gemcitabine, cisplatin or other platinum-based agents or history of allergic reactions attributed to any parenteral excipients (e.g. dimethylacetamide \[DMA\], Cremophor EL, Polysorbate 80, Solutol HS 15).
•4. Symptomatic central nervous system or leptomeningeal metastases.

Locations (125)

Arizona Oncology Associates , PC - HOPE

Tucson, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

The Oncology Institute of Hope and Innovation

Whittier, California, United States

Rocky Mountain Cancer Centers, LLP- Aurora

Aurora, Colorado, United States

Baptist Health Medical Group Oncology, LLC

Miami, Florida, United States

Orlando Health, Inc.

Orlando, Florida, United States

IACT Health

Columbus, Georgia, United States

Affiliated Oncologists LLC

Chicago Ridge, Illinois, United States

University of Kansas Medical Center Research Institute, Inc.

Westwood, Kansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Key Dates

Start Date

December 24, 2019

Primary Completion Date

March 2, 2022

Completion Date

April 5, 2022

Last Updated

May 24, 2023

Enrollment

773

ACTUAL participants

Conditions

Biliary Tract Cancer

Interventions

NUC-1031

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

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