Samuraciclib for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called samuraciclib for individuals with localized pancreatic cancer. The main goal is to assess the safety and effectiveness of this drug for this cancer type. Participants will take the drug daily and undergo various tests, such as CT scans and blood samples, to monitor progress. Individuals with non-metastatic pancreatic cancer might be suitable candidates, particularly if their cancer is identified as basal pancreatic adenocarcinoma. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but it mentions that certain medications, herbal supplements, or foods that strongly affect specific enzymes should not be taken within 21 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that samuraciclib is likely to be safe for humans?
Research has shown that samuraciclib is generally safe. In earlier studies, patients tolerated the treatment well, and the results were promising. Most reported side effects were mild, indicating that patients can manage the treatment. Additionally, samuraciclib has been tested for other types of cancer, supporting its potential safety for treating pancreatic cancer. So far, evidence suggests that samuraciclib is relatively safe for people in clinical trials.12345
Why do researchers think this study treatment might be promising for pancreatic cancer?
Unlike the standard treatments for pancreatic cancer, which often include chemotherapy drugs like gemcitabine and FOLFIRINOX, Samuraciclib offers a novel approach by targeting cyclin-dependent kinases (CDKs). CDKs are proteins that play a crucial role in cell division, and inhibiting them can potentially stop the cancer cells from multiplying. Researchers are excited about Samuraciclib because it represents a more targeted therapy, which may lead to fewer side effects and improved effectiveness, especially for patients who haven't responded well to traditional options. This new mechanism of action could pave the way for more personalized and precise treatment strategies in pancreatic cancer care.
What evidence suggests that samuraciclib might be an effective treatment for pancreatic cancer?
Research suggests that samuraciclib, the treatment under study in this trial, may help treat localized pancreatic cancer. Studies have shown that 55% of patients responded to the treatment, and patients without the TP53 gene mutation lived an average of 14.5 months without cancer progression. Additionally, early studies in various cancers have shown that tumors can shrink and the treatment is generally safe. These findings indicate that samuraciclib could be effective for pancreatic cancer patients, particularly those without certain genetic mutations.46789
Who Is on the Research Team?
Rachael Safyan, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic cancer that can be removed by surgery, is borderline resectable, or has spread only locally. Participants must have localized disease and meet health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive samuraciclib orally once daily for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Samuraciclib
Trial Overview
The study tests samuraciclib, a new drug, in people with certain types of pancreatic cancer. It also uses imaging scans and biopsies to monitor patients. The main goal is to see if samuraciclib is safe and effective.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive samuraciclib PO QD for 14 days on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients will have a research EUS/FNB on study. Patients also undergo CT scans during screening and blood sample collection on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Lopker Family Foundation
Collaborator
Carrick Therapeutics Limited
Industry Sponsor
The V Foundation for Cancer Research
Collaborator
Citations
Samuraciclib for the Treatment of Patients With Resectable, ...
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer. Detailed ...
2.
carricktherapeutics.com
carricktherapeutics.com/investors/news-events/press-releases/detail/27/carrick-therapeutics-announces-positive-results-from-phasePress Releases
Overall response rate (ORR) of 55% and median progression-free survival of 14.5 months in patients without TP53 gene mutation
Carrick Therapeutics Announces New Clinical Data ...
Two independent Phase 2 trials demonstrate extended progression-free survival in patients without TP53 mutations or without liver metastases.
4.
onclive.com
onclive.com/view/samuraciclib-plus-fulvestrant-improves-pfs-in-heavily-pretreated-hr-breast-cancerSamuraciclib Plus Fulvestrant Improves PFS in Heavily ...
Findings showed 72% (18 of 25) of evaluable patients had tumor shrinkage. median PFS was 32 weeks and 7.9 weeks, respectively … median PFS was ...
CDK7 Inhibitor
Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in breast cancer. In addition, it has shown signals ...
6.
carricktherapeutics.com
carricktherapeutics.com/news-media/press-releases/detail/27/carrick-therapeutics-announces-positive-results-from-phasePress Releases
Samuraciclib, an oral CDK7 inhibitor, has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in HR+ ...
7.
cancerresearchhorizons.com
cancerresearchhorizons.com/news-and-events/our-news/carrick-therapeutics-announces-first-patient-dosed-phase-1b/2-clinicalCarrick Therapeutics announces first patient dosed in ...
Samuraciclib has demonstrated a favourable safety profile ... samuraciclib has further potential in prostate, pancreatic, ovarian and colorectal cancers.
Dose escalation and expansion cohorts in patients with ... - PMC
In this study, samuraciclib exhibits tolerable safety and PK is supportive of once-daily oral administration. Clinical activity in TNBC and HR+/ ...
Recent advances in development of CDK7 inhibitors and their ...
This combination demonstrated excellent tolerability and an acceptable safety profile, characterized by low-grade AE (30,43). received U.S. ...
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