ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial
The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.
• Age 18 years or over
• Ability to understand and willing to sign a written informed consent form in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening to document their willingness to participate.
• Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i.e. primary diagnosis of ductal adenocarcinoma or acinar cell adenocarcinoma, inclusive of all subtypes)
• Treatment history meeting one of either:
∙ Stable disease or partial response to FOLFIRINOX (leucovorin calcium/folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin) after at least eight cycles of treatment (Cohort B)
‣ Progression of disease after receiving standard of care chemotherapies (Cohort A).
• i. There is no maximum number of prior lines
• ii. Patients with recurrence within six months of adjuvant-intent chemotherapy will be eligible
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Life Expectancy of greater than 12 weeks
• Patients must have acceptable organ function
• Patients must have baseline hepatitis B screening. If they have a positive surface antigen the case will discussed with the hepatologist to determine if therapy is indicated. This does not exclude them from study.
• Patients must agree to use effective contraceptive methods for the period required by the study.
⁃ Patients must have measurable disease
⁃ Patient-derived organoid is sensitive to a drug listed for this study, defined by
• Consensus agreement in molecular tumor boards, considering the totality of the genomic and organoid data, and the safety profile of the drug, and the clinical situation
∙ Sensitivity to a drug chosen for the study, based on
⁃ i. IC50 \< Cmax (maximum plasma concentration) ii. Area under the curve (AUC) \< 30th percentile of cohort iii. Individual assay fulfills quality control metrics c. Matched clinical scenario (maintenance versus treatment) as outlined in this protocol.
⁃ Able to swallow and tolerate oral medication (as applicable)