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Closed (no longer recruiting)Last updated: 29 May 2023

CX-5461: This phase I trial is evaluating an intravenously administered drug (CX-5461) for the treatment of advanced blood cancerA Phase 1, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CX-5461 in Patients with Advanced Haematologic Malignancies

Clinical summary


The study is evaluating the maximum tolerated dose (MTD) by understanding the safety profile during incremental dosage escalation. Who is it for? You may be eligible to join this study if you are aged over 18 years with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available, and have progressed following at least one prior treatment regimen. As every blood cancer patient has a unique disease and treatment history, it is highly suggested that you discuss the trial with your haematologist or oncologist who can also contact Peter Mac to determine whether this trial may be suitable for you. Trial details Participants in this study will receive CX-5461, an RNA polymerase I inhibitor. CX-5461 will be administered by intravenous infusion over 1 hour every 21 days. Seven dose levels are planned: 25 mg/m2, 50 mg/m2, 100 mg/m2, 170 mg/m2, 250 mg/m2, 330 mg/m2 and 450 mg/m2 per dose. Patients will be assigned to a dose level in the order of study entry. Participants will be required to undergo various assessment tests including blood, imaging, laboratory and physical assessment tests.


This trial is treating patients with advanced blood cancer.


Blood Cancers Blood


People18 - 75



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Commercial Sponsor

Peter MacCallum Cancer Centre

Scientific Title

A Phase 1, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Intravenously Administered CX-5461 in Patients with Advanced Haematologic Malignancies



  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.


  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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