Using Tumor Models to Determine Treatments
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
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
Treatments tested in this trial
- Cobimetinib
- Ponatinib
- Brigatinib
- Colchicine
- Selinexor
- Abemaciclib
- Neratinib
- Doxorubicin
- Etoposide
- Ceritinib
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov