Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

NCT04605913 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 3 other identifiers: MC210405NCI-2022-0152221-011320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.

Conditions

Pancreas Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Metastatic Adenocarcinoma

Keywords

GCN; TTF; Paclitaxel; Cisplatin; Gemcitabine; Tumor Treatment Fields

Outcome Measures

Primary Outcomes (1)

• Safety of (m)-GCN+TTF

  Assessed by incidence of adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  28 days

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  Six months

• Overall Response Rate (ORR)

  Six months

• Overall Survival (OS)

  Twelve months

• Time to Progression (TTP)

  Twelve months

• Quality of Life - EORTC QLQ-C30

  Every 2 months, up to 12 months

Study Arms (1)

Modified GCN+TTF treatment

EXPERIMENTAL

The trial will compose of 2 parts with a total of 40 subjects. The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1. If 6 patients tolerate the dose level of GCN+TTF through the 1st cycle without defined dose limiting toxicities (DLTs) or grade 4 treatment related adverse events (TRAE), the 2nd part of the study (phase Ib portion) will commence. An additional 34 patients will be enrolled in the expansion cohort (phase Ib).

Combination Product: Modified GCN+TTF treatment

Interventions

Modified GCN+TTF treatment COMBINATION_PRODUCT

The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1.

Also known as: NovoTTF-100L(P)

Modified GCN+TTF treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed pancreatic adenocarcinoma or adenosquamous carcinoma with liver metastasis. Liver metastasis can be confirmed histologically / cytologically or radiologically
• Subjects with additional sites of metastasis, except known brain metastasis, are eligible
• Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous and acinar-adenocarcinoma histologies can be enrolled
• Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (magnetic resonance imaging \[MRI\]/computed tomography \[CT\] scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult
• Patients with no prior lines of therapy for the treatment of stage IV metastatic disease
• Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy
• Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress \> 6 months after completion of the therapy
• Patients who progress while on adjuvant fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX) can enroll immediately
• Male and female patients at least 18 years of age
• Absolute neutrophil count (ANC) \> 1500 cells/mm\^3
• Platelet count \> 100,000 cells/mm\^3
• Hemoglobin \>= 8 g/dL
• Total bilirubin \< 1.5 X upper limit of normal (ULN)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 X ULN
• For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 6.0 X ULN and total bilirubin \< 3 x ULN

You may not qualify if:

• Previous front-line therapy for metastatic disease
• Patients with known brain metastasis
• Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker
• Patient with cardiac or abdominal pacemakers or stimulators
• Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction
• Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible
• Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug
• Known sensitivity to conductive hydrogels
• Patients who are pregnant or breastfeeding
• Patients who lack the capacity to consent for themselves

Sponsors & Collaborators

• Mayo Clinic: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Hani M. Babiker, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will compose of 2 parts with a total of 40 subjects. The 1st part would be a safety run-in phase (phase I). In this phase, 6 patients will be treated after completing screening procedures and meeting eligibility criteria. If 6 patients tolerate this dose level of GCN+TTF through the 1st cycle without defined dose limiting toxicities (DLTs) or grade 4 treatment related adverse events (TRAE), the 2nd part of the study (phase Ib portion) will commence. An additional 34 patients will be enrolled in the expansion cohort (phase Ib).

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 28, 2020
• Study Start: April 25, 2022
• Primary Completion: August 17, 2026
• Study Completion (Estimated): February 17, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

US (1)