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New treatment option for Pancreas Cancer
Official title Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC
ClinicalTrials.gov ID: NCT04605913
What this study is testing
What is Modified GCN+TTF treatment?
Modified GCN+TTF treatment is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pancreas cancer.
Also referred to as NovoTTF-100L(P).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
- people 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 histology 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...
- Patients with no prior lines of therapy for the treatment of stage IV metastatic disease.
You likely can't join if
- 1\. 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.
See the full eligibility criteria
- Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
- people 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 histology 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 (MRI/CT scan), with and without CA 19-9...
- 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 chemo-radiotherapy. i. Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress greater than 6 months after...
- Male and female patients at least 18 years of age
- Laboratory data as specified below: Hematology: \- ANC greater than 1500 cells/mm3, \- platelet count greater than 100,000 cells/mm3, and \- Hemoglobin greater than 8 g/dL.
- Hepatic
- Total bilirubin less than 1.5 X ULN;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less...
- Renal:
- serum creatinine WNL or creatinine clearance greater than 50 mL/min.
- QT intervals: QTc less than or equal to 470 msec for men and less than or equal to 490 msec for women. (As measured by Hodges' Equation: QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular...
- Estimated life expectancy of at least 3 months
- ECOG Performance Status 0-1.
- Ability to operate the Novo TTF-100L (P) 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...
- 1\. 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. 10\. Patients who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.