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 are 18 years of age or older at the time of giving consent
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2)
• People who have been diagnosed with pancreatic cancer (including certain subtypes such as adenocarcinoma, acinar carcinoma, squamous cell carcinoma, and adenosquamous carcinoma), have had surgery intended to fully remove the cancer, and currently show no signs of the cancer returning
• People who are planning to receive, are currently receiving, or have already completed at least 3 months (12 weeks) of chemotherapy using multiple drugs given around the time of surgery (before, after, or both), with up to 6 months of such treatment allowed; radiation or chemoradiation may also have been received in addition
• People whose most recent treatment (chemotherapy, radiation, or surgery) was no more than 12 weeks ago at the time of initial registration
• People who have a confirmed harmful or likely harmful change (mutation) in the BRCA1, BRCA2, or PALB2 gene, as identified by an approved and accredited laboratory
• People who, at the time of being assigned to a treatment group, have completed at least 3 months of the chemotherapy described above and have no signs of the cancer returning or spreading, confirmed by scans taken within the past 4 weeks
• People whose cancer did not get worse while they were receiving platinum-based chemotherapy
• People who are at least 3 weeks but no more than 12 weeks past their last treatment (chemotherapy, radiation, or surgery) at the time of being assigned to a treatment group
• People who have recovered from side effects of prior cancer treatment, with no remaining side effects above a mild level (except hair loss or nerve-related symptoms)
• People living with HIV who are on effective treatment and have had an undetectable level of the virus in the past 6 months
• People with a history of hepatitis B who have an undetectable viral load while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load
• People who are able to understand and willing to sign a written consent form, or who have a legally authorised representative to do so on their behalf
• People whose blood test results taken within 28 days before being assigned to a treatment group meet all of the following (confirm with trial site):
  • White blood cell count at or above an acceptable level
  • Neutrophil count (a type of immune cell) at or above an acceptable level
  • Platelet count at or above an acceptable level
  • Haemoglobin (a measure of red blood cells) at or above an acceptable level, without a blood transfusion in the past 28 days
  • Liver function values within acceptable ranges
  • Kidney function within an acceptable range

Who may not be able to join:

• People who have been diagnosed with a neuroendocrine tumour of the pancreas
• People who have had a previous allergic reaction to olaparib or to medicines with a similar chemical makeup
• People with a personal history of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), or who show features that suggest either condition (these are types of blood or bone marrow disorders)
• People with an uncontrolled digestive system disorder that, in the opinion of the treating doctor, would interfere with taking or absorbing olaparib tablets
• People who are pregnant or breastfeeding; a pregnancy test within 14 days before being assigned to a treatment group is required for anyone who could potentially become pregnant
• People who are not willing or able to use effective contraception or abstain from sex for the duration of the trial and for a set period after the last dose (6 months for females, 3 months for males); people must also not donate sperm during treatment and for 3 months after, and must not breastfeed during treatment and for 1 month after
• People currently taking certain strong medications that interact with a liver enzyme called CYP3A4/5 — examples include ketoconazole, itraconazole, ritonavir, clarithromycin, and similar drugs (confirm with trial site for full list)
• People currently being actively treated for another cancer, except those receiving hormone therapy after primary treatment or topical treatments for skin cancer
• People with certain serious, uncontrolled heart conditions, or with a condition called congenital long QT syndrome (a heart rhythm disorder)
• People with serious, uncontrolled medical conditions or active infections — examples include uncontrolled heart rhythm problems, a heart attack within the past 3 months, uncontrolled seizures, unstable spinal cord compression, a specific condition affecting blood flow to the upper body (superior vena cava syndrome), significant lung disease seen on detailed scans, or a psychiatric condition that prevents a person from giving informed consent
• People who are currently taking part in another clinical trial using an investigational (experimental) treatment
• People who have had major surgery within 2 weeks before being assigned to a treatment group, or who have not yet fully recovered from a major surgery
• People who have not had their genetic mutation confirmed as eligible by the central expert reviewer overseeing the trial
• People whose tumour tissue showed a BRCA1, BRCA2, or PALB2 mutation but who have not previously had germline (inherited) genetic testing and are unwilling to undergo it

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