Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence

Last updated: April 24, 2025
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Digestive System Neoplasms

Treatment

Treatment Plan

Clinical Study ID

NCT06228599
PRO00049951
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years.

  2. Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).

  3. Pancreatic tumor is surgically removed and

  4. patient has received multimodal therapy (neoadjuvant, sandwich or adjuvantchemotherapy ± radiation) or

  5. patient is ineligible for or refuses multimodal therapy.

  6. Patient has one of the following:

  7. Post-surgical cancer antigen (CA) 19-9 elevation (> 35 U/mL at least 6 weekspost-surgical resection) in the setting of bilirubin < 2 mg/dL (unlessbilirubin elevation is consistent with Gilbert's syndrome) OR

  8. High-risk pathological features, defined as positive surgical margin or lymphnode involvement in cancer.

  9. Patient has no definitive measurable disease recurrence or metastatic disease at thetime of first post-surgical imaging (in those with high-risk pathological features)or within four weeks of elevated CA 19-9 value as evidenced by appropriate imaging.

  10. Laboratory values:

  11. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.

  12. Platelet count ≥ 75,000/mm^3 (125 × 109/L).

  13. Hemoglobin (Hgb) ≥ 8 g/dL.

  14. aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamate-pyruvate transaminase (SGPT) ≤ 5 × upper limit of normal range (ULN).

  15. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3.

  16. At the time of treatment, patient should be off other anti-tumor agents for at leastfive half-lives of the agent or three weeks from the last day of treatment,whichever is shorter.

  17. Able to swallow and retain oral medication, if needed.

  18. Pregnancy It is not known what effects matched therapy has on human pregnancy ordevelopment of the embryo or fetus. Therefore, female subjects participating in thisstudy should avoid becoming pregnant, and male subjects should avoid impregnating afemale partner. Nonsterilized female subjects of reproductive age and male subjectsshould use effective methods of contraception through defined periods during andafter study treatment as specified below. Female participants: A female participant is eligible to participate if she is notpregnant, not breastfeeding, and at least one of the following conditions applies:

  • Not a female of childbearing potential (FCBP), defined as all female patientsthat were not in post-menopause for at least one year or are surgicallysterile, OR

  • An FCBP must have a negative serum pregnancy test and agree to use at least oneform of pregnancy prevention during the study for at least one month aftertreatment discontinuation unless otherwise noted by the agent(s) USPI, whichthe FCBP must follow. Male participants: A male participant, even if surgically sterilized (i.e., statuspost vasectomy), must use a form of barrier pregnancy prevention approved by theinvestigator or treating physician during the study and for at least one month aftertreatment discontinuation and refrain from donating sperm during this period unlessotherwise noted by the agent(s) USPI, which the male participant must follow.

  1. Patient must be presented at the Molecular Tumor Board (MTB) and agree to receivethe MTB-recommended therapy.

  2. Ability to understand a written informed consent document, and the willingness tosign it.

  3. Patients presented at the MTB prior to signing consent are eligible to be onstudy. Patients do not need to be presented again at the MTB prior to startingtherapy on trial unless six months elapse between consent and start of studytreatment.

Exclusion

Exclusion Criteria:

A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.

  1. CA 19-9 non-producers, unless high-risk pathological features present.

  2. Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).

  3. Radiographic evidence of metastatic disease.

  4. Inability to ingest study drugs by mouth.

  5. Diarrheal bowel movements > 6 per day postoperatively on maximal medical therapy.

  6. Patient has active, untreated, or uncontrolled bacterial, viral, or fungalinfection(s) requiring systemic intravenous therapy.

  7. 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) withinfour weeks prior to Day 1 of study therapy.

  8. Patient has a history of allergy or hypersensitivity to the study drug(s) or any ofthe excipients.

  9. Uncontrolled concurrent illness, including, but not limited to, unstable anginapectoris, uncontrolled and clinically significant cardiac arrhythmia, or psychiatricillness/social situations that would limit compliance with study requirements.

  10. Is pregnant or breastfeeding or any patient with childbearing potential not usingadequate pregnancy prevention.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Treatment Plan
Phase:
Study Start date:
February 29, 2024
Estimated Completion Date:
July 31, 2026

Study Description

This is a prospective, open-label, therapeutic interventional investigation designed to interrogate the efficacy and safety of personalized matched therapy in pancreatic cancer patients who have completed all intended multimodal therapy, including resection of the pancreatic cancer tumor. Potential participants must have their tumor tissue or blood molecularly profiled with the results discussed by the Molecular Tumor Board, whether convened in person, virtually (e.g., WebEx), or in an electronic forum (e.g., email). Only those patients who agree to receive the Molecular Tumor Board-recommended matched therapy (i.e., study treatment) will be eligible and enrolled on the study.

Connect with a study center

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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