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New treatment option for Metastatic Pancreatic Adenocarcinoma
Official title Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT06576115
What this study is testing
What is Nab paclitaxel?
Nab paclitaxel is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for metastatic pancreatic adenocarcinoma.
Also referred to as Abraxane.
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
- The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.
- Phase 2: a mid-size study of how well it works
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
- Patients must have histologically or cytologically proven advanced metastatic adenocarcinoma of the pancreas. Patients with mixed tumor with...
- One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT or MRI or PET scans
- If female patient is of childbearing potential must have a negative serum pregnancy test (βhCG) documented up to 48 hrs prior to administration of...
- Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of...
- Age above 18 years
You likely can't join if
- Patients who have had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or...
- Patients receiving any other investigational agents.
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive...
- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and...
- No history of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated...
- Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels such as amlodipine, nifedipine...
See the full eligibility criteria
- Patients must have histologically or cytologically proven advanced metastatic adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
- One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT or MRI or PET scans
- If female patient is of childbearing potential must have a negative serum pregnancy test (βhCG) documented up to 48 hrs prior to administration of chemotherapy.
- Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6...
- Age above 18 years
- Based on prior studies, patients 80 years of age and older are considered to be at higher risk for fatal neutropenic sepsis. These patients should be thoroughly evaluated including geriatric assessment prior to...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Parameter Levels: Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets \> 100,000/mcL Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) \ 50
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
- Patients who have had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or neo-adjuvant setting.
- Patients receiving any other investigational agents.
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of...
- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and nab-paclitaxel.
- No history of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
- Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not allowed in the study unless their medical treatment...
- Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy is...
- Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study...
- Patient with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis.
- Pregnant women are excluded from this study because of potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment...
- Patient has localized resectable or locally advanced tumor.
- Patients has undergone major surgery, other than diagnostic surgery or procedures, within 4 weeks prior to the treatment day.
- Patients is unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study.
- Patient is enrolled in any other clinical treatment trial.
The study team makes the final eligibility decision.
Where it's taking place
- Clarkston, Michigan, United States
- Detroit, Michigan, United States
- Flint, Michigan, United States
- Lansing, Michigan, United States
- Lapeer, Michigan, United States
- Petoskey, Michigan, United States
- Port Huron, Michigan, 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 Clarkston, Michigan, United States; Detroit, Michigan, United States; Flint, Michigan, United States; Lansing, Michigan, United States; Lapeer, Michigan, United States; Petoskey, Michigan, United States and 1 more location(s). 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.