Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT04158635
Eligibility Criteria:
Main Inclusion Criteria
* Adult patients with unresectable pancreatic carcinoma
* Patients must be a candidate to receive one of the following chemotherapy combinations as determined by the treating physician:
Arm A2: gemcitabine plus nab-paclitaxel given every 2 weeks (arm A1 is closed per this amendment)
Arm B: mFOLFIRINOX given every 2 weeks
* Willingness to permit study team to obtain and use archival tissue, if already existing, or, be willing to undergo a fresh tumor biopsy if clinically possible (exceptions may be provided by study PI if medically unsafe to perform biopsy).
* Weight ≥ 40 kg
* ANC ≥ 1500/mm3; platelets ≥ 100,000/mm3
* AST, ALT ≤ 1.5 x ULN. Patients with liver metastases ≤ 3 x ULN
* Total serum bilirubin ≤ 1.5 x ULN
* Creatinine clearence ≥ 60 mL/min
Main Exclusion Criteria
* Current or planned use of Warfarin, Cyclosporine A, Rifampicin, Glyburide (other diabetic medications are allowed)
* Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
* Strong inhibitors or inducers of CYP2C9
* Strong inhibitors or inducers of CYP3A
* Agent or agents that moderately inhibit both CYP2C9 and CYP3A (via a single concomitant agent, or co-administration of concomitant agents)
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
* Current or history of ≥ Grade 2 peripheral neuropathy
* Known allergy to eggs or any of the components within the study agents and/or their excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04158635
Study Brief:
Protocol Section:
NCT04158635