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RNA Polymerase I Inhibitor

CX5461 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, CX5461, to see if it is more effective than standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Confirm the recommended phase II dose and schedule of CX5461 in patients with solid tumours
Secondary outcome measures
Assess pharmacokinetics of CX5461
Number and severity of adverse events in patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: CX-5461Experimental Treatment1 Intervention
CX5461 as intravenous infusion on day 1 and day 8 every 4 weeks. A day 1 every 3 weeks schedule may be used if the day 1 and day 8 every 4 weeks schedule is not tolerable
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pidnarulex
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,412 Total Patients Enrolled
Senhwa Biosciences, Inc.Industry Sponsor
6 Previous Clinical Trials
401 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,253 Total Patients Enrolled

Frequently Asked Questions

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

Do any openings remain for individuals to partake in this clinical trial?

"The records on clinicaltrials.gov indicate that this research project is not enrolled in patient recruitment, as the last update was posted on July 13th 2022. Despite no longer searching for participants, 486 other trials are still open to enrollment at present."

Answered by AI

Has CX5461 been given the nod of approval by the FDA?

"Limited clinical data has been collected on CX5461's efficacy and safety, consequently earning it a score of 1."

Answered by AI
Recent research and studies
Nature CommunicationsJournal
CX-5461 Is a DNA G-quadruplex Stabilizer with Selective Lethality in BRCA1/2 Deficient Tumours
Xu, Hong, Marco Di Antonio, Steven McKinney, Veena Mathew, Brandon Ho, Nigel J. O’Neil, Nancy Dos Santos, et al.. 2017. “CX-5461 Is a DNA G-quadruplex Stabilizer with Selective Lethality in BRCA1/2 Deficient Tumours”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/ncomms14432.
Nature CommunicationsJournal
Results of the Phase I CCTG IND.231 Trial of CX-5461 in Patients with Advanced Solid Tumors Enriched for Dna-repair Deficiencies
Hilton, John, Karen Gelmon, Philippe L. Bedard, Dongsheng Tu, Hong Xu, Anna V. Tinker, Rachel Goodwin, et al.. 2022. “Results of the Phase I CCTG IND.231 Trial of CX-5461 in Patients with Advanced Solid Tumors Enriched for Dna-repair Deficiencies”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-022-31199-2.
Nature CommunicationsJournal
Results of the Phase I CCTG IND.231 Trial of CX-5461 in Patients with Advanced Solid Tumors Enriched for Dna-repair Deficiencies
Hilton, John, Karen Gelmon, Philippe L. Bedard, Dongsheng Tu, Hong Xu, Anna V. Tinker, Rachel Goodwin, et al.. 2022. “Results of the Phase I CCTG IND.231 Trial of CX-5461 in Patients with Advanced Solid Tumors Enriched for Dna-repair Deficiencies”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-022-31199-2.
clinicaltrials.govStudy
A Phase I Study of CX5461
2016. "A Phase I Study of CX5461". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02719977.
~5 spots leftby Apr 2025
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