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New treatment option for Metastatic Pancreatic Cancer
Official title Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients
ClinicalTrials.gov ID: NCT05929885
What this study is testing
What is Low Dose OXIRI (LD-OXIRI)?
Low Dose OXIRI (LD-OXIRI) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99
You may be able to join if
- The patient must meet all of the to participate in the study.
- Aged above 21
- Histopathological diagnosis of pancreatic cancer
- Advanced disease not amenable to curative resection (locally advanced or metastatic disease)
- Measureable disease by RECIST 1.1 criteria
You likely can't join if
- Any patient meeting any of the exclusion criteria at baseline will be excluded from participation.
- History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell...
- Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable...
- Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol...
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- Treatment with palliative chemotherapy or radiotherapy within 4 weeks prior to enrolment into the study
See the full eligibility criteria
- The patient must meet all of the to participate in the study.
- Aged above 21
- Histopathological diagnosis of pancreatic cancer
- Advanced disease not amenable to curative resection (locally advanced or metastatic disease)
- Measureable disease by RECIST 1.1 criteria
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate hematologic function (granulocyte count ≥ 1.5 × 10\ \ 9/L, platelet count ≥ 100 × 10\ \ 9/L),
- Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal [ULN], AST and ALT, ALP ≤ 3 x ULN or \< 5 x ULN in case of hepatic involvement),
- Adequate renal function (creatinine clearance \> 50 mL/min) will be eligible for inclusion into the study.
- Able to provide written and informed consent
- Any patient meeting any of the exclusion criteria at baseline will be excluded from participation.
- History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and...
- Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT or...
- Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- Treatment with palliative chemotherapy or radiotherapy within 4 weeks prior to enrolment into the study
- Major surgery within two weeks prior to enrolment into the study
- Patients on chronic immunosuppressive therapy
- Pregnancy, lactation or inadequate contraception. Women of childbearing potential must have a negative pregnancy test within 3 days of enrolment and agree to use a reliable means of contraception. Men must have been...
- Patients on anticoagulant therapy with vitamin K antagonists.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.