A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors (NCT04214093) | Clinical Trial Compass
TerminatedPhase 1
A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors
Stopped: Strategic change to clinical development plan
United States9 participantsStarted 2019-12-16
Plain-language summary
This is a first-time-in-human (FTIH), Phase 1 study to determine the safety, tolerability, maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) of AZD0466 in patients with solid tumors, lymphoma and multiple myeloma at low risk for tumor lysis syndrome (TLS), as well as in patients at intermediate risk or high risk of TLS with hematologic malignancies for whom no standard therapy exists. Once an MTD/RP2D has been determined in the dose escalation portion, further disease-specific expansions (solid tumor and hematologic) will be undertaken. Combinations of AZD0466 with other standard of care treatments may be evaluated in the future.
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated written informed consent prior to any study specific procedures, sampling and analyses
. Documented active disease requiring treatment that is relapsed or refractory as determined by RECIST or clinically defined changes.
. Aged ≥18 yrs
. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 without 2 levels of ECOG deterioration within 2 weeks (wks) of signing the ICF
. Life expectancy ≥12 wks
. Measurable or evaluable disease according to disease-specific tumor assessment criteria
. Adequate hepatic/renal function at screening:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of Dose Limiting Toxicities (DLTs)
Timeframe: 28 days for Arm A; between 35 and 56 days for Arm B due to varying number of ramp-up doses
2
The incidence of adverse events
Timeframe: Minimum observation period 28 days for Arm A and between 35 and 56 days for Arm B due to varying number of ramp-up doses; and will continue until the subject is off the study (approximately 6 months)
. Adequate cardiac function demonstrated by left ventricular ejection fraction ˃50% on screening echocardiogram
Exclusion criteria
. Patient has non-secretory myeloma
. Patient has idiopathic thrombocytopenic purpura
. Previously refractory to platelet transfusion within 1 yr
. Treatment with any of the following:
. All toxicities from prior cancer therapy greater than NCI-CTCAE Grade (Gr) 1 will have returned to Gr1 at the time of enrollment with the exception of alopecia. Patients with Gr≤2 neuropathy are eligible.
. Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 21 days previously and there is no evidence of CNS disease progression or mild neurologic symptoms.
. Presence or history of CNS lymphoma, leptomeningeal disease or spinal cord compression
. Active infection including HIV, Hepatitis B, or Hepatitis C