15 Participants NeededMy employer runs this trial

Samuraciclib for Pancreatic Cancer

RS
IB
Overseen ByIsabel Blanco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

RS

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

Absolute neutrophil count ≥ 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
See 11 more

Exclusion Criteria

Receiving other investigational agents
Uncontrolled or concurrent illness including active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
Breastfeeding or pregnancy
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
CT scans and blood sample collection

Treatment

Participants receive samuraciclib orally once daily for 14 days

2 weeks
Endoscopic ultrasound with fine needle biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
Follow-up visits at 30 and 90 days

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

Group I: Treatment (Samuraciclib)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Lopker Family Foundation

Collaborator

Carrick Therapeutics Limited

Industry Sponsor

Trials
5
Recruited
290+

The V Foundation for Cancer Research

Collaborator

Trials
21
Recruited
1,300+

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 ...

Press 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.

Samuraciclib 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 ...

Press Releases

Samuraciclib, an oral CDK7 inhibitor, has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in HR+ ...

Carrick 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. ...