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:

Criteria that apply to all participants:

• A BRAF gene fusion or rearrangement has been detected through an approved genetic test, including blood-based tests.
• The cancer cannot be fully removed by surgery, or it has come back after previous treatment.
• Any brain, spinal, or surrounding membrane involvement is not causing symptoms that require surgery or radiation treatment.
• There is no fluid buildup around the heart, lungs, or abdomen that requires treatment.
• No anti-cancer drugs have been taken in the 14 days before joining, and no experimental drugs (targeted therapy or immunotherapy) have been taken in the 21 days before joining.
• No surgery under general anaesthesia has taken place in the 28 days before joining.
• No radiation therapy of any kind has been received in the 14 days before joining.
• The heart is pumping at 50% or better, confirmed by a heart scan done within 28 days before joining.
• Recent blood test results (taken within 14 days before joining, without recent blood transfusions or growth factor injections) fall within acceptable ranges for blood cell counts, liver function, and kidney function (confirm with trial site for specific values).
• The person is able to swallow tablets or capsules.
• People who could become pregnant agree to use contraception for at least 30 days after the last dose and to avoid egg donation during that time; people who could father children agree to use contraception for at least 90 days after the last dose and to avoid sperm donation during that time.
• Written informed consent has been provided; for participants under 18, both the participant and a parent or legal guardian must sign the consent form.

Additional criteria for Cohort A (low-grade brain tumour group):

• A tissue biopsy has confirmed a low-grade glioma (Grade 1 or 2) according to the World Health Organization classification.
• The participant is 12 years of age or older; participants aged 12–17 must weigh at least 40 kg; there is no weight requirement for those 18 and over.
• The participant has a functional ability score of 70 or above on the appropriate scale for their age group (confirm with trial site).
• A measurable tumour is visible on imaging taken within 28 days before joining.
• Appropriate initial treatment has been completed, the participant is neurologically stable, and imaging does not show multiple or spreading lesions.
• Steroid medication has not been increased in the 14 days before joining, and the current steroid dose is at or below a moderate level (equivalent to 50 mg prednisolone or less).

Additional criteria for Cohort B (pancreatic cancer group):

• A tissue biopsy has confirmed pancreatic cancer.
• The cancer has continued to grow after at least one round of chemotherapy (not counting post-surgery preventive chemotherapy).
• The participant is 18 years of age or older.
• The participant has a good general performance level, rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activity).
• A measurable tumour is visible on a contrast-enhanced CT scan taken within 28 days before joining.

Who may not be able to join:

• People who currently have another active cancer, unless it is one of several specific early-stage or fully treated cancers with no recurrence for more than five years (confirm with trial site for the full list).
• People who have had moderate-to-severe heart failure symptoms or a significant heart rhythm problem in the past six months.
• People who have had a heart attack or unstable chest pain in the past six months.
• People whose heart's electrical activity shows a prolonged QT interval on a recent ECG.
• People who currently have an infection that requires treatment with systemic medication.
• People with high blood pressure that is not well controlled (above 150/100 mmHg).
• People who have had a blockage in the blood vessels of the eye (retinal vein occlusion), or who have certain eye conditions that increase that risk.
• People who have a history of certain other eye or retinal conditions (confirm with trial site for the full list).
• People with diabetes that is not well controlled.
• People who have had a blood clot in a vein (such as a deep vein clot or a clot in the lungs) in the past three months.
• People who have a muscle or nerve disease associated with elevated muscle enzyme levels.
• People who have previously been treated with a type of drug called a MEK inhibitor.
• People who have had a severe allergic reaction to binimetinib or any of its ingredients.
• People who test positive for HIV, active hepatitis B, or hepatitis C.
• People who test negative for active hepatitis B but show certain markers suggesting past exposure, and also test positive for hepatitis B genetic material in the blood (confirm with trial site).
• People who have a condition affecting how their digestive system absorbs food or medication.
• People who are pregnant, breastfeeding, or may be pregnant.
• People with a psychiatric illness or psychological condition that would interfere with taking part in the trial.
• People considered unsuitable for the trial by the supervising doctor for any other reason.

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