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New treatment option for Pancreas Cancer
Official title Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
ClinicalTrials.gov ID: NCT06228599
What this study is testing
- What it's testing
- This is a prospective, open-label therapeutic interventional investigation designed to interrogate the efficacy and safety of individualized matched therapies in patients with pancreatic cancer at high risk of disease recurrence post-surgery.
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
- Age ≥18 years.
- Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
- Pancreatic tumor is surgically removed and
- patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
- patient is ineligible for or refuses multimodal therapy.
You likely can't join if
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- CA 19-9 non-producers, unless high-risk pathological features present.
- Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
- Radiographic evidence of metastatic disease.
- Inability to ingest study drugs by mouth.
- Diarrheal bowel movements \> 6 per day postoperatively on maximal medical therapy.
See the full eligibility criteria
Who can join
- Age ≥18 years.
- Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
- Pancreatic tumor is surgically removed and
- patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
- patient is ineligible for or refuses multimodal therapy.
- Patient has one of the following:
- Post-surgical cancer antigen (CA) 19-9 elevation (\> 35 U/mL at least 6 weeks post-surgical resection) in the setting of bilirubin \< 2 mg/dL (unless bilirubin elevation is consistent with Gilbert's syndrome) OR
- High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
- Patient has no definitive measurable disease recurrence or metastatic disease at the time of first post-surgical imaging (in those with high-risk pathological features) or within four weeks of elevated CA 19-9 value as...
- Laboratory values:
- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.
- Platelet count ≥ 75,000/mm\^3 (125 × 109/L).
- Hemoglobin (Hgb) ≥ 8 g/dL.
- aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamate-pyruvate transaminase (SGPT) ≤ 5 × upper limit of normal range (ULN).
- Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3.
- At the time of treatment, patient should be off other anti-tumor agents for at least five half-lives of the agent or three weeks from the last day of treatment, whichever is shorter.
- Able to swallow and retain oral medication, if needed.
- Pregnancy It is not known what effects matched therapy has on human pregnancy or development of the embryo or fetus. Therefore, female people participating in this study should avoid becoming pregnant, and male people...
- Not a female of childbearing potential (FCBP), defined as all female patients that were not in post-menopause for at least one year or are surgically sterile, OR
- An FCBP must have a negative serum pregnancy test and agree to use at least one form of pregnancy prevention during the study for at least one month after treatment discontinuation unless otherwise noted by the agent(s)...
- Patient must be presented at the Molecular Tumor Board (MTB) and agree to receive the MTB-recommended therapy.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Patients presented at the MTB prior to signing consent are eligible to be on study. Patients do not need to be presented again at the MTB prior to starting therapy on trial unless six months elapse between consent and...
What rules you out
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- CA 19-9 non-producers, unless high-risk pathological features present.
- Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
- Radiographic evidence of metastatic disease.
- Inability to ingest study drugs by mouth.
- Diarrheal bowel movements \> 6 per day postoperatively on maximal medical therapy.
- Patient has active, untreated, or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic intravenous therapy.
- Patient has undergone or planned major surgery other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to Day 1 of study therapy.
- Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.
- Uncontrolled concurrent illness, including, but not limited to, unstable angina pectoris, uncontrolled and clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance...
- Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, 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 Milwaukee, Wisconsin, 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.