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Cyclin-Dependent Kinase (CDK) Inhibitor

Fadraciclib for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Cyclacel Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is studying a new cancer drug to see if it is safe and works well.

Who is the study for?
Adults (18+) with advanced solid tumors or lymphoma, who've tried all standard treatments without success or have no standard options available. They must be able to take oral medication, have a performance status indicating they can carry out daily activities with ease or some limitation, and agree to use birth control if there's any chance of conception.Check my eligibility
What is being tested?
The trial is testing Fadraciclib, an oral drug taken twice daily. It's in early stages (phase 1/2) to see how safe it is and how well it works for cancer that has worsened despite treatment. The study will also look at how the body processes the drug and its effects on tumor biology.See study design
What are the potential side effects?
Specific side effects of Fadraciclib are not listed here but may include typical reactions seen with cancer therapies such as fatigue, digestive issues, blood cell changes leading to increased infection risk, liver function alterations, and potential heart-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has worsened despite standard treatments, or I can't tolerate them.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I can swallow pills and don't have major stomach or bowel issues affecting medicine absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Overall Response Rate (ORR)
Secondary outcome measures
AUC
Adverse events
Cmax
+2 more
Other outcome measures
Pharmacodynamics
Pharmacogenomics

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I Dose escalationExperimental Treatment1 Intervention
Phase I = Fadraciclib administered orally in escalating doses starting at 50mg bid MWF for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved. Phase 2 = Recommended Fadraciclib phase 2 dose and schedule administered orally in 28 day cycles.

Find a Location

Who is running the clinical trial?

Cyclacel Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
2,149 Total Patients Enrolled
3 Trials studying Lymphoma
364 Patients Enrolled for Lymphoma
Mark H Kirschbaum, MDStudy ChairCyclacel Pharmaceuticals, Inc.
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Fadraciclib (Cyclin-Dependent Kinase (CDK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04983810 — Phase 1 & 2
Lymphoma Research Study Groups: Phase I Dose escalation
Lymphoma Clinical Trial 2023: Fadraciclib Highlights & Side Effects. Trial Name: NCT04983810 — Phase 1 & 2
Fadraciclib (Cyclin-Dependent Kinase (CDK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04983810 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are in this experiment?

"Yes, the information available on clinicaltrials.gov suggests that this research is actively searching for subjects. The trial was originally posted on July 12th 2021 and updated most recently on April 1st 2022. There are 2 locations involved in the study, and a total of 330 participants are needed between both sites."

Answered by AI

Are there other drugs that have been studied in combination with Fadraciclib?

"Fadraciclib was first researched in 2015 by the Dana-Farber Cancer Institute. In subsequent years, 5 further clinical trials have been conducted with many of these taking place in Duarte, California."

Answered by AI

Are patients being enrolled in this trial at this time?

"The trial, which can be found on clinicaltrials.gov, is looking for volunteers. The listing was first posted on July 12th 2021 and updated most recently on April 1st 2022."

Answered by AI

Is this the first time this experiment has been conducted?

"Fadraciclib clinical trials began in 2015. The first trial, sponsored by Cyclacel Pharmaceuticals, Inc., occurred that same year and involved 70 patients. After the initial study yielded positive results, Fadraciclib received Phase 1 drug approval in 2015. As of now, there are five ongoing trials for this medication taking place across three countries and five cities."

Answered by AI
~95 spots leftby Apr 2025