Phase 1 Colorectal 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 taking part in the dose escalation phase must have a laboratory-confirmed cancer that has spread or cannot be surgically removed, and that has continued to grow after standard treatments that included the drugs fluorouracil (5-FU) or capecitabine.
• People with colorectal cancer taking part in the dose escalation phase must be willing and able to have a tumour biopsy taken before treatment starts.
• People taking part in the dose expansion phase must have laboratory-confirmed colorectal cancer that has spread or cannot be surgically removed, and that has continued to grow after standard treatments that included 5-FU or capecitabine.
• People in the dose expansion phase must be willing and able to have tumour biopsies taken both before and during treatment.
• People must have cancer that can be measured on scans.
• People must be 18 years of age or older (children are excluded because safety data in this age group is not yet available).
• People must have a general health and activity level rated at a moderate level or better (ECOG performance status 0–2, or Karnofsky score of 60% or higher).
• A stored sample of tumour tissue must be available at the time of enrolment for testing.
• Any previous systemic cancer treatment must have been completed at least two weeks before starting this trial, or for a period of at least five half-lives of that treatment, whichever is shorter.
• Blood counts must meet minimum levels: neutrophils at least 1,000 per microlitre and platelets at least 100,000 per microlitre.
• Liver function blood test results must be within acceptable ranges set by the testing laboratory.
• Kidney function must meet a minimum threshold (confirm with trial site for exact values).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the last 6 months may be eligible.
• People with chronic hepatitis B must have an undetectable viral load while on suppressive therapy, if that therapy is needed.
• People with a history of hepatitis C must have completed treatment and been cured, or if currently on treatment, must have an undetectable viral load.
• People who have had brain metastases that have been treated may be eligible if follow-up brain scans show no sign of the cancer growing after that treatment.
• People who have or have had another cancer may be eligible if that cancer and its treatment are not expected to interfere with this trial's safety or results.
• People must have a heart health rating of class 2B or better under a standard heart function classification scale.
• People who are able to become pregnant, and men, must agree to use adequate contraception during the trial and for 6 months after completing treatment, as the effects of the trial drugs on an unborn baby are unknown.
• People must be willing and able to understand and sign a written consent form, or have a legally authorised representative do so on their behalf.

Who may not be able to join:

• People who have previously been treated with a class of drugs called BET inhibitors.
• People who have previously been unable to tolerate capecitabine at the dose planned for this trial.
• People currently taking certain blood-thinning medications known as oral Factor Xa inhibitors (such as rivaroxaban or apixaban) or Factor IIa inhibitors (such as dabigatran) — a different type of blood thinner (low molecular weight heparin) is allowed.
• People whose treatment for HIV, hepatitis B, or hepatitis C would interfere with the trial drugs (for example, through drug interactions).
• People with stomach or bowel conditions that would affect the ability to take or absorb oral medications.
• People whose cancer has spread extensively to the liver (more than 30% of the liver involved) or throughout the lining of the abdomen.
• People with untreated or uncontrolled cancer in the brain or central nervous system.
• People known to have a specific enzyme deficiency called DPD deficiency, which affects how the body processes certain chemotherapy drugs.
• People with serious ongoing illness or other significant health conditions.
• People who are unable or unwilling to follow the trial procedures or attend follow-up appointments.
• People who still have side effects from previous cancer treatment that are rated above a mild level (above grade 1), except for hair loss or nerve-related side effects up to grade 2.
• People currently taking part in another clinical trial involving an experimental treatment.
• People with a history of serious allergic reactions to drugs with a similar composition to the trial drugs.
• People taking medications that strongly affect the way the body processes a liver enzyme called CYP3A4 — these medications would need to be stopped a set number of days before starting the trial (confirm with trial site for specific timing and drug names).
• People who are pregnant, as the trial drugs may harm an unborn baby.
• People who are breastfeeding, as the effects of the trial drugs on a nursing infant are unknown.

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