Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with advanced or metastatic pancreatic cancer (of any cell type), confirmed through a tissue or cell sample test
• People whose cancer has a specific genetic change — either an FGFR gene fusion/translocation or an activating FGFR mutation — confirmed by an approved laboratory test
• People whose cancer falls into one of two groups: Cohort 1 is for pancreatic cancer with an FGFR2 fusion/translocation and no KRAS mutation; Cohort 2 is for pancreatic cancer with other FGFR1, 3, or 4 gene changes, where a KRAS mutation is permitted
• People whose cancer has gotten worse after at least one standard treatment, or who could not tolerate that treatment
• People who have not previously been treated with a different FGFR inhibitor medication
• People who have measurable or detectable disease on scans, as assessed by standard medical criteria
• People aged 18 or older, of any gender
• People who are generally well enough to carry out light activity and care for themselves (a standard medical fitness score of 0 or 1; a score of 2 may be considered on a case-by-case basis — confirm with trial site)
• People who are able to swallow and keep down tablets taken by mouth
• People who have recovered from most side effects of previous cancer treatments (hair loss and mild nerve-related symptoms from prior treatment may still be present)
• People who have had brain metastases in the past that were successfully treated with surgery or radiation, and whose follow-up scans show the brain disease is stable and causing no symptoms
• People who are able and willing to attend scheduled visits, follow the treatment plan, and have regular blood tests
• People who are able to read and/or understand the study details and sign a consent form approved by the relevant ethics committee

Who may not be able to join:

• People who are experiencing worsening neurological symptoms from their cancer that require increasing doses of steroid medications (stable steroid use for at least 2 weeks before starting the trial may be acceptable — confirm with trial site)
• People who currently have symptoms from brain metastases
• People with a history of another cancer, unless it was a skin cancer (non-melanoma), cervical cancer in situ, or another cancer that was fully treated and is not expected to return or affect survival during the study
• People with any other medical condition that the trial doctor believes would make participation unsafe or difficult
• People with current eye problems affecting the cornea or retina (the surface or back of the eye), confirmed by an eye examination
• People with a history of widespread calcium deposits in soft tissues or organs such as the kidneys, gut, heart muscle, or lungs (minor or symptom-free calcifications may be acceptable — confirm with trial site)
• People with digestive conditions that could significantly affect how the study drug is absorbed, such as active ulcers, uncontrolled nausea, vomiting, diarrhoea, poor nutrient absorption, or previous removal of part of the small bowel
• People with current disorders affecting the body's calcium or phosphate balance, such as parathyroid gland problems or a history of parathyroid surgery
• People who have received certain recent cancer treatments too close to the start of the trial, including chemotherapy, biological therapies (such as antibody treatments), targeted small molecule drugs, other experimental treatments, or recent radiotherapy — the required waiting periods vary by treatment type (confirm with trial site)
• People currently taking strong medications that significantly affect how the body processes the study drug (CYP3A4 inhibitors or inducers), or medications that raise phosphorus or calcium levels in the blood, or certain anti-seizure medications
• People who have consumed grapefruit, pomegranate, star fruit, pomelo, Seville oranges, or related products within 7 days before the first dose
• People whose blood test results fall outside required ranges, including low white blood cell counts, low platelets, low haemoglobin, high liver enzyme levels, high bilirubin, or reduced kidney function (specific thresholds apply — confirm with trial site)
• People whose blood calcium or phosphate levels fall outside the normal range for the testing institution
• People with significant or uncontrolled heart conditions, such as unstable angina, a recent heart attack, severe heart failure, or a heart rhythm problem requiring treatment (people with a well-controlled pacemaker for at least one month may be eligible — confirm with trial site)
• Women who are pregnant or breastfeeding
• Women who are physically capable of becoming pregnant, unless a highly effective method of contraception is used during treatment and for 3 months after finishing the study drug (acceptable methods include surgical sterilisation, hormonal contraception, or an IUD — periodic abstinence and withdrawal are not considered acceptable)
• Sexually active men, unless they use a condom during intercourse throughout treatment and for 3 months after the last dose, including men who have had a vasectomy

Important: Always verify eligibility with the trial site directly before applying.