Search / Trial NCT06228599

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

Launched by MEDICAL COLLEGE OF WISCONSIN · Jan 18, 2024

Apply for Trial

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Pancreatic Cancer Molecular Profile Targeted Therapy

ClinConnect Summary

This clinical trial is exploring a new approach to treat patients who have had surgery for pancreatic cancer and are at high risk of the cancer coming back. The study aims to test individualized therapies that are tailored to each patient's specific cancer characteristics. Patients who participate will receive treatments based on their unique molecular profiles, which may help improve their chances of staying cancer-free after surgery.

To be eligible for the trial, participants must be at least 18 years old, have had their pancreatic tumor surgically removed, and show signs of being at high risk for recurrence, such as specific cancer markers or features found during pathology. Patients should not have any visible signs of cancer spread at the time of joining the study. Throughout the trial, participants can expect to receive close monitoring and will need to follow certain health guidelines. It's also important for potential participants to know that women who can become pregnant or men must take precautions to avoid pregnancy during the study. If you're interested or think you might qualify, please talk to your doctor for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 1. Age ≥18 years.
  • • 2. Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
  • • 3. Pancreatic tumor is surgically removed and
  • • 1. patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
  • • 2. patient is ineligible for or refuses multimodal therapy.
  • 4. Patient has one of the following:
  • • 1. 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
  • • 2. High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
  • • 5. 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 evidenced by appropriate imaging.
  • 6. Laboratory values:
  • • 1. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.
  • • 2. Platelet count ≥ 75,000/mm\^3 (125 × 109/L).
  • • 3. Hemoglobin (Hgb) ≥ 8 g/dL.
  • • 4. aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamate-pyruvate transaminase (SGPT) ≤ 5 × upper limit of normal range (ULN).
  • • 7. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3.
  • • 8. 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.
  • • 9. Able to swallow and retain oral medication, if needed.
  • • 10. Pregnancy It is not known what effects matched therapy has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Nonsterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below.
  • Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • • 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) USPI, which the FCBP must follow.
  • • Male participants: A male participant, even if surgically sterilized (i.e., status post vasectomy), must use a form of barrier pregnancy prevention approved by the investigator or treating physician during the study and for at least one month after treatment discontinuation and refrain from donating sperm during this period unless otherwise noted by the agent(s) USPI, which the male participant must follow.
  • • 11. Patient must be presented at the Molecular Tumor Board (MTB) and agree to receive the MTB-recommended therapy.
  • • 12. Ability to understand a written informed consent document, and the willingness to sign it.
  • • 1. 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 start of study treatment.
  • 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 fungal infection(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) within four weeks prior to Day 1 of study therapy.
  • • 8. Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.
  • • 9. 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 with study requirements.
  • • 10. Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.

Trial Officials

Mandana Kamgar, MD, MPH

Principal Investigator

Medical College of Wisconsin

Razelle Kurzrock, MD

Principal Investigator

Medical College of Wisconsin

Douglas Evans, MD

Principal Investigator

Medical College of Wisconsin

About Medical College Of Wisconsin

The Medical College of Wisconsin (MCW) is a leading academic institution dedicated to advancing healthcare through innovative research, education, and clinical practice. As a prominent clinical trial sponsor, MCW is committed to conducting high-quality, ethically-guided research that aims to improve patient outcomes and address critical health challenges. Leveraging a multidisciplinary approach, MCW collaborates with a diverse network of healthcare professionals, researchers, and community partners to facilitate groundbreaking clinical trials across various medical fields, ensuring the translation of scientific discoveries into effective treatments and practices.

Locations

Milwaukee, Wisconsin, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0