None listed
Conditions
Brief 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 on day 1 and day 8 every 28 days. Four dose levels are planned: 70 mg/m2, 100 mg/m2, 150 mg/m2 and 220 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.
Interventions
This is a Phase I study of CX-5461, an RNA polymerase I inhibitor. 40 patients with histologically confirmed relapsed or refractory advanced haematologic malignancies, who have progressed following at least one prior treatment regimen, will be enrolled in the study. CX-5461 will be administered by intravenous infusion over 1 hour on day 1 and day 8 every 28 days. Four dose levels are planned: 70 mg/m2, 100 mg/m2, 150 mg/m2, 220 mg/m2, per dose. Patients will be assigned to a dose level in the or
This is a Phase I study of CX-5461, an RNA polymerase I inhibitor. 40 patients with histologically confirmed relapsed or refractory advanced haematologic malignancies, who have progressed following at least one prior treatment regimen, will be enrolled in the study. CX-5461 will be administered by intravenous infusion over 1 hour on day 1 and day 8 every 28 days. Four dose levels are planned: 70 mg/m2, 100 mg/m2, 150 mg/m2, 220 mg/m2, per dose. Patients will be assigned to a dose level in the order of study entry. Patients may continue to receive an infusion of CX-5461 every 3 weeks until disease progression, occurance of unacceptable toxicities, or the decision of the patient and/or Investigator
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available. These patients must have progressed following at least one prior treatment regimen. There must be evidence of measurable disease.
Exclusion criteria
Pregnant or lactating women, uncontrolled intercurrent illness, history of other malignancy within 2 years of study entry (excluding treated nonmelanotic skin cancer and in-situ carcinoma), known CNS involvement unless previously treated and well controlled for a period of >=3 months and does not require the use of steroids.
Outcome results
None listed