Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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

Male or<br/>FemaleGender Male or
Female

Closed (no longer recruiting)Status Closed (no longer recruiting)

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18-75Age 18-75

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaLeukaemia,Lymphoma,Multiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is evaluating an intravenously administered drug (CX-5461) for the treatment of advanced blood cancer.
 

This trial is treating patients with advanced blood cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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 may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

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.

Not Recruiting Hospitals Read MoreRead more

Closed

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Nathan Reader Wilson
PCCTU.EDD@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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