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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ashish Manne
Study ID
NCT05624918
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Apr 2026
Primary completion
Aug 29, 2027
Completion
Aug 29, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Group
    Nab-paclitaxel + gemcitabine + NovoTTF-200T(P) for 3 cycles (28 day cycles) Participants who have stable disease or better after the first 3 cycles of treatment will undergo pancreatectomy within 8 weeks of receiving treatment. If the surgery yields R0 or R1 then patient will receive another 3 cycles of treatment regimen (within 8 weeks of surgery). Those who do not undergo surgery will still be included in the evaluable patients for the objectives

Primary Outcome Measure

2 Year Overall Survival (OS) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Barbara Kleiber, MACPR, BSN, RN
614-293-1815
Ashish Manne, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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