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New treatment option for Pancreatic Ductal Carcinoma
Official title Using Tumor Models to Determine Treatments
ClinicalTrials.gov ID: NCT06813079
What this study is testing
What is Cobimetinib?
Cobimetinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pancreatic ductal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i.e. primary diagnosis of ductal adenocarcinoma or acinar cell adenocarcinoma...
- Treatment history meeting one of either:
- Stable disease or partial response to FOLFIRINOX (leucovorin calcium/folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin) after at...
You likely can't join if
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
- 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...
- Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
- Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for...
- Patients with a history of a severe allergic reaction attributed to compounds of similar or biologic composition to the PDO matched drug may be...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Able to swallow and tolerate oral medication (as applicable)
What rules you out
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works 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.
- Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially...
- Patients with a history of a severe allergic reaction attributed to compounds of similar or biologic composition to the PDO matched drug may be excluded if assessed by the investigator and determined to be unsafe to...
- Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in...
- Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
- Patients with known left ventricular ejection fraction (LVEF) \< 40 % as determined by a multigated acquisition (MUGA) scan or echocardiogram.
- Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
- Patients with acute gastrointestinal bleeding within one month prior to the screening step.
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance...
- Lactating and nursing women.
- Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.