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 range18 Years – 130 Years
SexALL
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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:
✓. Adequate cardiac function demonstrated by left ventricular ejection fraction ˃50% on screening echocardiogram
Exclusion criteria
✕. Patient has non-secretory myeloma
✕
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)
✕. 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