Table 3.
Clinical trials of various therapeutic drugs used for the treatment and preventive studies of IPMN
| Drug | Candidates | Age | Gender | Allocation | Dosage Time Period | Follow Up | Current Status |
|---|---|---|---|---|---|---|---|
| Celecoxib/COX-2 Inhibitor NCT00198081 |
Patients diagnosed with IPMN | 18 Years and older | All | Non-Randomized | Oral 200mg BID twice a day 6–8 weeks prior to surgery for surgical candidate and for 6 months for others | EUS or ERCP after 6 months | Phase-2 Terminated |
| Sulindac NCT04207944 |
Patients diagnosed with high-risk IPMN | 21–85 Years old | All | Randomized double-blind placebo controlled | Oral 200mg BID /day 3 years | Assessment of serum CMP, CBC, and CA19-9 every 6 months, EUS performed 6 months after randomization (+/− 4 weeks) and then annually. Pancreatic CT performed 1 year after randomization (+/− 4 weeks) and then annually such that EUS and CT is alternative | Phase-2 Ongoing |
| Erlotinib Hydrochloride NCT00482625 |
Patients diagnosed with IPMN, Recurrent, Stage IA, Stage IB, Stage IIA, Stage IIB, Stage III Pancreatic Cancer | 18 Years and older | All | Non-applicable (N/A) | 100mg orally once daily for 21–42 days before surgery | Surgery after treatment, protein/MUC5AC expression analysis, IPMN cells numbers, analysis of Erlotinib levels in plasma and pancreas | Phase-2 Terminated |
| Delta-Tocotrienol NCT00985777 |
Patients diagnosed with IPMN, MCN, PDAC | 18 Years and older | All | Non-applicable (N/A) | Orally twice daily. Either 100-mg, 200-mg, or 400-mg capsules for 14 consecutive days and one dose on Day of surgery | Study of Safety, bioavailability, Pharmacokinetics, and Pharmacodynamics for total 12 weeks per participants | Phase 1 Completed |
| NanoPac NCT0318899 |
Mainly Patients diagnosed with MCN and BD-IPMN | 18 Years and older | All | Non-Randomized | 6mg/ml, 10mg/ml, 15 mg/ml in a volume sufficient to fill or equal to the amount of cyst fluid aspirated in dose escalation phase. In second phase, best dose with 2 injections administered 12 weeks apart by intra-cystic injection | Patients followed for 6 months. Plasma sample collection at 1 and 2 hours after injection and subsequent visits for pharmacokinetics and cyst volume assessment by imaging | Completed |