Clinical trial for Resectable Pancreatic Ductal Adenocarcinoma
Official title Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer
ClinicalTrials.gov ID: NCT07645651
What this study is testing
What is Samuraciclib?
This is an investigational oral medicine being studied as a potential treatment for resectable pancreatic ductal adenocarcinoma. It is designed to block a protein called CDK7, which helps control how fast cells grow and divide.
Also referred to as CT7001.
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 study aims to see how safe and effective samuraciclib is for treating localized pancreatic cancer.
- Who it's for
- Patients who have resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma.
- Phase 1: an early, usually small safety study
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 proven basal pancreatic adenocarcinoma.
- Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells...
- Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic...
- There must be no evidence of metastatic disease
- Must be 18 years or older
You likely can't join if
- Prior radiation
- Unable to tolerate oral medication, per assessment of the principal investigator (PI)
- Participants who are receiving other investigational agents
- Concomitant mediation use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions or...
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection with clinically significant sequelae that...
See the full eligibility criteria
- Histologically or cytologically proven basal pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
- Basal tumors are defined as GATA6- and HMGA2+. Tumor cores are considered positive for GATA6 or HMGA2 if greater than 10% of tumor epithelial cells had positive nuclei
- Resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma (PDA) at diagnosis based on contrast-enhanced CT or magnetic resonance imaging (MRI) (CT or MRI without contrast as part of...
- There must be no evidence of metastatic disease
- Must be 18 years or older
- Ability to understand and willingness to sign a written informed consent document
- Archival biopsy specimen collected within 3 months must be available. If not available, a diagnostic EUS/FNB will be performed during screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count (ANC) ≥ 1,500/mcL (within 14 days prior to study drug)
- Platelets ≥ 100,000/mcL (within 14 days prior to study drug)
- Hemoglobin ≥ 9 g/dL (within 14 days prior to study drug)
- Creatinine clearance ≥ 50 ml/min by Cockcroft-Gault
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5X ULN (within 14 days prior to study drug)
- Total bilirubin ≤ 1.5X ULN (within 14 days prior to study drug)
- Participants must not be pregnant or nursing. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours of treatment initiation, where WOCBP are defined as all female participants...
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Prior radiation
- Unable to tolerate oral medication, per assessment of the principal investigator (PI)
- Participants who are receiving other investigational agents
- Concomitant mediation use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or how well it...
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection with clinically significant sequelae that precluded adequate absorption of samuraciclib
- Uncontrolled seizures
- Active infection
- Active bleeding diatheses
- Known active hepatitis B or hepatitis C infection
- Breastfeeding or pregnancy
- Receipt of systemic corticosteroids within 14 days before the first dose of study medication
- Receipt of St. John's Wort within 21 days before the first dose of study medication or of another concomitant medication, herbal supplement, or food that was a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or...
- Known hypersensitivity to samuraciclib or any excipient of the product
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, 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, but 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?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.