Health TrialsbyHealthPanel

Using Tumor Models to Determine Treatments

ConditionsPancreatic Ductal CarcinomaAdvanced CancerEpithelial Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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)

Disqualifiers

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Patient received last dose of chemotherapy within 21 days prior to Cycle 1 Day 1.

Patients with ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment.

Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cobimetinib

    Drug

    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.

  • Ponatinib

    Drug

    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.

  • Brigatinib

    Drug

    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.

  • Colchicine

    Drug

    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.

  • Selinexor

    Drug

    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.

  • Abemaciclib

    Drug

    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.

  • Neratinib

    Drug

    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.

  • Doxorubicin

    Drug

    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.

  • Etoposide

    Drug

    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.

  • Ceritinib

    Drug

    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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Cohort AExperimental treatment 10 interventions
Group B: Cohort BExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
3 years

Secondary outcomes

1

Disease control rate (DCR)

Time frame
3 years
2

Duration of response (DOR)

Time frame
3 years
3

Progression free survival (PFS)

Time frame
3 years
4

Overall survival (OS)

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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