NCT05624918

A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

A Phase II Study of Peri-Operative NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Ashish Manne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.

Conditions

• Pancreatic Adenocarcinoma
• Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nab paclitaxel	125 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle
DRUG	Gemcitabine	1000 mg/m\^2 IV over 30 minutes or per site standard on days 1, 8, and 15 of a 28 day cycle
DEVICE	NovoTTF-200T(P)	Worn \> 18 hr /day starting C1D1 until completion of cycle 3

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-08-29
• Completion: 2028-08-29
• First posted: 2022-11-22
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study