NCT06813079

Using Tumor Models to Determine Treatments

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PDO is a three-dimensional experimental model grown in a laboratory from patient's tumour tissues. PDO is used to test different drugs and select the drugs that may work for treating the patient's cancer. Researchers will review participants' PDO drug results from other studies from which they participated in and will identify the drug that seem to have the best effect on the PDO model. Participants will be offered to receive that drug during the study.

Conditions

• Pancreatic Ductal Carcinoma
• Advanced Cancer
• Epithelial Tumor

Interventions

Type	Name	Description
DRUG	Cobimetinib	Cobimetinib is an antineoplastic agent and selective inhibitor of the mitogen-activated extracellular kinase (MEK) pathway. Participants will take cobimetinib by mouth (orally), once a day on days 1 to 21 followed by a 7-day break of each cycle. A cycle will be 28 days in length.
DRUG	Ponatinib	Ponatinib is a type of drug called a protein tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins that act as chemical messengers to stimulate cancer cells to grow. Ponatinib blocks and interferes with a number of protein kinases. It is called a multi kinase inhibitor. Participants will take ponatinib by mouth (orally), once a day, every day of each cycle. A cycle will be 28 days.
DRUG	Brigatinib	Brigatinib is a type of cancer growth blockers called a tyrosine kinase inhibitor (TKI). It blocks chemical signals (enzymes) from tyrosine kinase proteins. Tyrosine kinases help to send growth signals in cells, so blocking them stops the cell growing and dividing. Participants will take brigatinib by mouth (orally), once a day for the first 7 days. If participants are able to tolerate the dose during the first 7 days, they will take the doubled dose orally, once a day until end of the cycle (day 8 to day 28). Each cycle will be 28 days in length.
DRUG	Colchicine	Colchicine is an alkaloid that affects the way the body responds to uric acid crystals, and reduces swelling and pain. On the first day, participants will take two tablets of colchicine by mouth (orally), then one tablet orally one hour later. Starting the second day, participants will take one tablet of colchicine once or twice a day, every day of each cycle. A cycle will be 28 days in length. The study doctor will decide whether participants will take colchicine once or twice a day.
DRUG	Selinexor	Selinexor blocks a protein called CRM1, a protein within the cell, and may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor. Participants will take selinexor by mouth (orally), once a week on days 1, 8, 15, and 22 of each cycle. A cycle will be 28 days in length.
DRUG	Abemaciclib	Abemaciclib belongs to a class of medications called kinase inhibitors. Abemaciclib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Participants will take abemaciclib by mouth (orally), twice a day, every day of each cycle. A cycle will be 28 days in length.
DRUG	Neratinib	Neratinib is a targeted cancer drug that works on a protein called human epidermal growth factor receptor 2 (HER2). HER2 proteins make cells divide and grow. Some cancers have large amounts of HER2 proteins which can cause cancer cells to divide and grow faster. Neratinib works by locking onto the HER2 on the cancer cells. So it stops the cells from growing. Participants will take neratinib by mouth (orally), once a day, every day of each cycle. Dose will increase weekly, until week 3. On week 3 and onward, participants will take the same dose. A cycle will be 28 days in length.
DRUG	Doxorubicin	Doxorubicin is a type of chemotherapy drug called an anthracycline. It slows or stops the growth of cancer cells by blocking an enzyme called topo isomerase 2. Cancer cells need this enzyme to divide and grow. Participants will receive doxorubicin by vein (intravenous infusion or IV) in clinic, over 60-90 minutes, once every cycle. A cycle will be 21 days in length. Participants may receive 6-8 cycles of study drug.
DRUG	Etoposide	Etoposide is a chemotherapy drug that destroys quickly dividing cells, such as cancer cells. Participants will receive etoposide by mouth (orally), twice a day, on days 1 to 7 of every cycle. On days 8 to 21, there will be no dosing. A cycle will be 21 days in length.
DRUG	Ceritinib	Ceritinib is a tyrosine kinase inhibitor. It works by blocking an enzyme called anaplastic lymphoma kinase (ALK). Ceritinib only works in cancer cells that have an overactive version of ALK. Participants will take ceritinib by mouth (orally), once a day, every day of each cycle. A cycle will be 28 days in length.

Timeline

• Start date: 2025-02-17
• Primary completion: 2028-02-17
• Completion: 2028-02-17
• First posted: 2025-02-06
• Last updated: 2025-02-18

Locations

1 site across 1 country: Canada