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CDK Inhibitor
Fadraciclib for Leukemia and Myelodysplastic Syndrome
Phase 1 & 2
Waitlist Available
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 who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for leukemia or MDS, and will look at safety and effectiveness.
Who is the study for?
This trial is for adults with Leukemia or Myelodysplastic Syndrome (MDS) who haven't responded to standard treatments or have no standard options available. Participants must be in good physical condition, able to take oral medication, and not have significant heart disease, active infections requiring IV antibiotics, other primary cancers within the last 2 years (with some exceptions), or GI conditions affecting drug absorption.Check my eligibility
What is being tested?
The study is testing Fadraciclib (CYC065), an oral medication given twice daily. It's designed to see if this drug is safe and effective for treating Leukemia and MDS. The trial has two parts: Phase 1 checks safety at different doses while Phase 2 looks at how well it works against these diseases.See study design
What are the potential side effects?
While specific side effects of Fadraciclib are not listed here, common ones may include nausea, vomiting, diarrhea due to its effect on the digestive system; fatigue; potential blood disorders; liver issues; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a bone marrow transplant and don't have severe graft disease or active fungal infection.
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I am fully active or can carry out light work.
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I can take pills and don't have major gut issues affecting medicine absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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
Adverse events
Other outcome measures
Correlative studies
Pharmacodynamics
Pharmacogenomics
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase I Dose escalationExperimental Treatment1 Intervention
Phase 1 = 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.
Group II: Phase 2Experimental Treatment1 Intervention
Recommended fadraciclib phase 2 dose and schedule administered orally in 28-day cycles.
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Who is running the clinical trial?
Cyclacel Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
2,269 Total Patients Enrolled
7 Trials studying Leukemia
1,075 Patients Enrolled for Leukemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished any previous treatments 2 weeks ago and have recovered from side effects.I am 18 years old or older.I can take pills and don't have major gut issues affecting medicine absorption.I have not had major surgery in the last 4 weeks.I have heart problems that affect my daily activities.I have an ongoing inflammatory bowel condition or had a GI perforation recently.I am currently on IV antibiotics for an infection.My AML has spread to the lining of my brain and spinal cord.I haven't been vaccinated for COVID-19 in the last 3 months and might have been exposed to it recently.I have active hepatitis B or C.I do not have diseases that affect my stomach or intestines' ability to absorb medication.I had cancer before, but it was either non-invasive, skin cancer removed by surgery, or I've been cancer-free for 2+ years without treatment.I have HIV with an uncontrolled viral load and take medication that could affect metabolism.I finished treatments with decitabine or azacitidine over 3 weeks ago.I am fully active or can carry out light work.I can use Hydroxyurea for the first 14 days and will stop Valproic acid 72 hours before starting fadraciclib.I had a bone marrow transplant and don't have severe graft disease or active fungal infection.I haven't had cancer treatment or I've recovered from its side effects within the last 14 days or 5 half-lives.I am not pregnant or able to father a child, or I agree to use birth control during the study.I don't have any health or mental conditions that could affect the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Dose escalation
- Group 2: Phase 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment slots still available for this research project?
"Affirmative. Clinicaltrials.gov data reveals that this trial began recruiting on October 22, 2021 and is still actively seeking participants as of April 1st 2022. 210 patients are needed from 2 different sites."
Answered by AI
Is this research pioneering within its field?
"Since 2015, fadraciclib has been subject to clinical trials. The first of which was conducted by Cyclacel Pharmaceuticals, Inc., and involved 70 participants; this study granted the drug its Phase 1 approval. At present time, five active studies are being held in three different countries across five cities."
Answered by AI
Are there any past experiments pertaining to fadraciclib?
"Currently, 5 active clinical trials researching fadraciclib are in progress with 0 entering Phase 3. Primarily based in Duarte, California, the 11 trial centres distributed across America are working hard to advance our understanding of this medication."
Answered by AI
How many participants are anticipated for this research project?
"Affirmative, the clinical trial in question is actively enrolling patients according to information hosted on clinicaltrials.gov. This study was initially advertised on October 22nd 2021 with its most recent update occurring April 1st 2022; they are looking for 210 individuals at 2 sites."
Answered by AI
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