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.

Phase I – Dose Escalation (for people with various solid tumours)

Who might be able to join this trial:

• People aged 18 to 70 years (male or female) who are able to understand the study risks, are willing to follow the study procedures, and have signed a consent form
• People with a solid tumour (confirmed by laboratory testing of tissue or cells) that has spread or cannot be removed by surgery, and for which standard treatments no longer exist or are no longer working
• People with a general health status rated as fully active or able to carry out light activity (ECOG score of 0 or 1)
• People with a life expectancy of at least 12 weeks
• People who have recovered from side effects of previous cancer treatments to a mild or absent level
• People with kidneys, liver, and bone marrow that are functioning adequately

Who may not be able to join:

• People who have had another separate cancer diagnosis within the past 2 years, except for certain low-risk cancers (such as adequately treated skin cancers or early-stage cancers) that are unlikely to affect the study results
• People who have had major surgery (not including diagnostic procedures) within 4 weeks before the study start date
• People who have received radiation therapy, chemotherapy, biological therapy, targeted therapy, or hormone therapy within 4 weeks before the study start date
• People who have taken part in another clinical trial or received an experimental treatment within 4 weeks before the study start date
• People currently taking a diabetes medication called repaglinide, or certain other medications that strongly or moderately affect specific liver enzymes (CYP2C8, CYP2B6, or CYP2C9) — confirm specific medications with the trial site
• People who have fluid build-up around the lungs or in the abdomen that needs to be drained every two weeks or more often
• People with a hepatitis B (HBV) infection where the virus is present at or above a certain level in the blood (≥ 2,000 IU/mL)
• People with an active, uncontrolled bacterial, viral, or fungal infection that requires systemic (whole-body) treatment
• People with a history of HIV infection or syphilis infection
• People with certain heart conditions, including: severe heart failure (NYHA Class III or IV); an abnormal heart rhythm measurement on an ECG beyond certain thresholds; a heart attack, bypass surgery, or stent procedure within the past 6 months; or other heart conditions the trial doctor considers unsuitable
• Women who are pregnant or breastfeeding
• People with another illness or condition that the trial doctor believes would put them at unacceptable risk or interfere with the study
• People with a known allergy to ethanol, polyoxyethylene (35) castor oil, or N,N-dimethylacetamide (ingredients used in the study treatment)
• People who are unwilling or unable to follow the study procedures for any reason

Phase II – Pancreatic Cancer

Who might be able to join this trial:

• People aged 18 to 70 years (male or female) who are able to understand the study risks, are willing to follow the study procedures, and have signed a consent form
• People with pancreatic cancer (confirmed by laboratory testing of tissue or cells) that cannot be removed by surgery or controlled by local treatment, and for which standard treatments no longer exist or are no longer working
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1)
• People who are able to provide tumour tissue samples (including previously archived samples) for testing, and whose tumour tissue tests strongly positive for a protein called AKR1C3
• People with a general health status rated as fully active or able to carry out light activity (ECOG score of 0 or 1)
• People with a life expectancy of at least 12 weeks
• People who have recovered from side effects of previous cancer treatments to a mild or absent level
• People with kidneys, liver, and bone marrow that are functioning adequately

Who may not be able to join:

• People who have had another separate cancer diagnosis within the past 2 years, except for certain low-risk cancers (such as adequately treated skin cancers or early-stage cancers) that are unlikely to affect the study results
• People who have had major surgery (not including diagnostic procedures) within 4 weeks before the study start date
• People who have received radiation therapy, chemotherapy, biological therapy, targeted therapy, or hormone therapy within 4 weeks before the study start date
• People who have taken part in another clinical trial or received an experimental treatment within 4 weeks before the study start date
• People currently taking a diabetes medication called repaglinide, or certain other medications that strongly or moderately affect specific liver enzymes (CYP2C8, CYP2B6, or CYP2C9) — confirm specific medications with the trial site
• People who have fluid build-up around the lungs or in the abdomen that needs to be drained every two weeks or more often
• People with a hepatitis B (HBV) infection where the virus is present at or above a certain level in the blood (≥ 2,000 IU/mL)
• People with an active, uncontrolled bacterial, viral, or fungal infection that requires systemic (whole-body) treatment
• People with a history of HIV infection or syphilis infection
• People with certain heart conditions, including: severe heart failure (NYHA Class III or IV); an abnormal heart rhythm measurement on an ECG beyond certain thresholds; a heart attack, bypass surgery, or stent procedure within the past 6 months; or other heart conditions the trial doctor considers unsuitable
• Women who are pregnant or breastfeeding
• People with another illness or condition that the trial doctor believes would put them at unacceptable risk or interfere with the study
• People with a known allergy to ethanol, polyoxyethylene (35) castor oil, or N,N-dimethylacetamide (ingredients used in the study treatment)
• People who are unwilling or unable to follow the study procedures for any reason

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