Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03205176 | AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas | PHASE1 | COMPLETED | 49 | — | — | Jun 30, 2017 | Apr 8, 2021 | May 6, 2021 | 4 | United States, Canada |
DLTs will be determined from monitoring adverse events (AEs), and abnormal laboratory tests (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs (blood pressure and pulse), and electrocardiogram (ECG).
| Arm | Type | Description |
|---|---|---|
| AZD5153 Monotherapy | EXPERIMENTAL | Patients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine maximum tolerated dose (MTD). AZD5153 will be taken once per day (QD) or two times per day (BID) for 21 days as an oral capsule. Once the MTD is finalized, patients may be enrolled into an expansion cohort at the MTD. |
| AZD5153 + Olaparib Combination Therapy | EXPERIMENTAL | Patients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine MTD. AZD5153 will be taken as oral capsules BID in combination with 300 mg olaparib BID for 21 days. |
| Name | Type | Description |
|---|---|---|
| AZD5153 | DRUG | AZD5153 is to be taken as oral capsules once or twice per day each day in 21 day cycles. Dosing will continue until disease progression or other study discontinuation criteria are met. |
| Olaparib | DRUG | Olaparib, 300 mg, will be taken BID as oral capsules. |
Inclusion Criteria for all Patients: 1. Patient must be able to understand the nature of the study and provide a signed and dated, written informed consent prior to any study specific procedures, sampling or analyses. 2. Patients should have the ability and willingness to comply with the study and ...