Pancreas CancerPhase 1/2NCT04605913
Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC
A Phase 1/2 study testing Modified GCN+TTF treatment in people with Pancreas Cancer and Metastatic Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- Modified GCN+TTF treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 17 Feb 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Serum creatinine within normal limits (WNL) or creatinine clearance > 50 mL/min
- QT intervals: corrected QT (QTc) =< 470 msec for men and =< 490 msec for women (as measured by Hodges' Equation)
- Estimated life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Ability to operate the Novo TTF-100L (P) / Novo TTF-200T system
- Patients must have measurable disease on scans per RECIST 1.1
- Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma
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.
Read the detailed description
GCN is predicted to be the front-line therapy for biliary and pancreatic cancer in the future given excellent results of current early clinical trials (ORR ≥ 67% in pancreatic cancer). This will change standard of care for front-line therapy in patients with stage IV pancreatic cancer. In this cohort of patients' tolerability after 6 cycles of therapy will be a challenge. Investigators hypothesize that developing a maintenance strategy with TTF+G will be cutting edge approach and can potentially transform front-line standard of care therapy in patients with stage IV pancreatic cancer. If this pilot study proves fruitful then a larger study to confirm findings can be conducted.
- Conditions
- Pancreas Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma, Metastatic Adenocarcinoma
- Being tested
- Modified GCN+TTF treatment
- Keywords
- GCN, TTF, Paclitaxel, Cisplatin, Gemcitabine, Tumor Treatment Fields
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified GCN+TTF treatmentCombination product
Also called NovoTTF-100L(P)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Combination Product: Modified GCN+TTF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of (m)-GCN+TTF
Assessed by incidence of adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 28 days
Secondary outcomes (5)
Progression-free Survival (PFS)
PFS is defined as the time from the date of registration to the earliest date of documented evidence of recurrent or progressive disease or the date of death due to any cause.
Measured: Six months
Overall Response Rate (ORR)
ORR will be assessed by the percentage of patients achieving complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), as evaluated using the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
Measured: Six months
Overall Survival (OS)
OS is defined as the time from the date of registration to the date of death due to any cause, or the date of last contact (censored observations).
Measured: Twelve months
Time to Progression (TTP)
TTP is defined as the length of time from the date of registration until the disease starts to get worse or spread to other parts of the body.
Measured: Twelve months
Quality of Life - EORTC QLQ-C30
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire a questionnaire used to assess the quality of life of cancer patients. Twenty-eight questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much), and two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
Measured: Every 2 months, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start25 Apr 2022
- Primary completion17 Aug 2026
- Study completion17 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
- Investigators
- Hani M. Babiker, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605913
- Sponsor's protocol ID
- MC210405
- Other IDs
- NCI-2022-01522, 21-011320
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2020
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes