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CYC140 for Advanced Cancers and Lymphoma

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

ECOG performance status of 0-2

Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new drug, CYC140, to see if it is safe and effective in treating advanced solid tumors and lymphoma.

Who is the study for?

Adults (≥18 years) with advanced solid tumors or lymphoma that have worsened after standard therapy, or when no standard treatment is available. They must be able to take oral medication and not have GI issues affecting drug absorption. Participants need a stable health status, confirmed by an ECOG score of 0-2, and agree to use effective birth control.Check my eligibility

What is being tested?

The trial is testing CYC140, taken orally daily in two phases: Phase 1 for safety and dosage in various cancers; Phase 2 focuses on effectiveness in specific cancers. It's open-label so everyone knows they're getting the drug, and it measures how the body processes it.See study design

What are the potential side effects?

While specific side effects of CYC140 are not listed here, common ones from similar cancer drugs include nausea, fatigue, risk of infection due to lowered immunity, diarrhea or constipation, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I can swallow pills and don't have major stomach or bowel issues affecting drug absorption.

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My advanced cancer has worsened despite standard treatments, or I can't tolerate them.

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I had a stem cell transplant and don't have active fungal infections or severe graft-versus-host disease.

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

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

+6 more

Other outcome measures

Pharmacodynamics

Pharmacogenomics

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention

Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles.

Group II: Phase 1 Dose EscalationExperimental Treatment1 Intervention

Phase 1 = CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 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.

0 / 4Eligibility criteria met

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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

Media Library

Lymphoma Clinical Trial 2023: CYC140 Highlights & Side Effects. Trial Name: NCT05358379 — 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 participants are being sought for this research trial?

"In order to start the trial, 330 individuals who meet the specific study requirements are needed. These patients can choose to participate at multiple sites, such as City of Hope in Duarte, California and MD Anderson Cancer Center in Houston, Texas."

Answered by AI

Are we still able to accept participants for this research project?

"The latest information from clinicaltrials.gov suggests that this study is still actively recruiting patients. The trial was first posted on April 14th, 2022 and had its last update on October 18th of the same year."

Answered by AI

What are the primary goals of this clinical trial?

"The primary goal of this trial, as measured over the course of 18 months, is to establish the maximum tolerated dose. Additionally, researchers will be looking at overall survival rates, area under the concentration curve (AUC), and half-life (T1/2) as secondary objectives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma

2022. "A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05358379.