What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly those involving cyclin-dependent kinase (CDK) inhibitors like Fadraciclib, often include side effects such as myelosuppression (leading to anemia, neutropenia, and thrombocytopenia), fatigue, gastrointestinal disturbances (nausea, vomiting, diarrhea), and increased risk of infections. Other potential side effects can include liver enzyme abnormalities, mucositis, and alopecia. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved treatments for lymphoma involve cyclin-dependent kinase (CDK) inhibitors. One notable example is the use of trilaciclib, an intravenous CDK 4/6 inhibitor, which has been approved to decrease myelosuppression in patients receiving chemotherapy for extensive-stage small cell lung cancer, a condition related to lymphoma. Additionally, other CDK inhibitors like palbociclib, ribociclib, and abemaciclib have been approved for various cancers and are being explored for their efficacy in treating lymphomas. These drugs work by inhibiting the activity of CDK enzymes, which are crucial for cell cycle progression, thereby potentially controlling the proliferation of cancer cells.

What other types of research exist?

Promising novel alternatives to Fadraciclib for lymphoma patients include: 1) Ruxolitinib, a Janus kinase inhibitor, which has shown efficacy in various hematologic malignancies including lymphoma. 2) Venetoclax, a BCL-2 inhibitor, which has demonstrated significant activity in combination therapies for relapsed and refractory lymphomas. 3) CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, which have been approved for certain types of lymphoma and continue to show promising results in ongoing studies. 4) Bispecific antibodies like mosunetuzumab, which target CD20 and CD3, offering a novel mechanism of action for treating lymphoma.

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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

Must not have

Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism

Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral drug, Fadraciclib, for patients with advanced cancers or lymphomas who have no other treatment options. The drug works by blocking proteins that help cancer cells grow.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV with an uncontrolled viral load and take medication that could affect metabolism.

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I have active hepatitis B or C.

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I don't have any health or mental conditions that could affect the study.

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I have not had major surgery in the last 4 weeks.

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I am currently on IV antibiotics for an infection.

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I haven't had cancer treatments or still have side effects within the last 3 weeks.

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I do not have diseases that affect my stomach or intestines' ability to absorb medication.

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I have heart problems that affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose

Overall Response Rate (ORR)

Secondary study objectives

AUC

Adverse events

Cmax

+2 more

Other study objectives

Pharmacodynamics

Pharmacogenomics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fadraciclib

2023

Completed Early Phase 1

~10

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lymphoma treatments often target the rapid proliferation of cancer cells. Cyclin-dependent kinase (CDK) inhibitors like Fadraciclib work by blocking enzymes essential for cell cycle progression, thereby halting cancer cell division and inducing apoptosis. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Targeted therapies, such as monoclonal antibodies, specifically attack cancer cells with certain markers, sparing normal cells. These mechanisms are crucial for lymphoma patients as they offer multiple strategies to control and potentially eradicate the disease, improving survival rates and quality of life.

The treatment of Burkitt lymphoma in adults.[Staging and Treatment Response Evaluation in Malignant Lymphomas - Czech Lymphoma Study Group Recommendations According to Criteria Revised in 2014 (Lugano Classification)].