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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02482311 | Safety, Tolerance, PK, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours | PHASE1 | COMPLETED | 92 | — | — | Jul 1, 2015 | Aug 22, 2019 | Jul 3, 2023 | 16 | United States, Canada |
The AZD1775 dose is considered safe and tolerable if ≤ 1 of 6 patients experiences a DLT.
| Arm | Type | Description |
|---|---|---|
| AZD1775 | EXPERIMENTAL | Single-arm study. AZD1775 will be administered for 3 consecutive days at the start of week 1 and week 2 of each 21-day cycle. This study will be conducted in two parts, designated Part A and Part B. Part A is a safety lead-in. Part B will commence after the safety lead-in and will investigate the safety and efficacy of AZD1775 monotherapy in expansion cohorts of specific tumour types. |
| Name | Type | Description |
|---|---|---|
| AZD 1775 | DRUG | AZD1775 will be taken orally approximately every 12 hours over 3 days at the start of week 1 and week 2 of each 21-day cycle (Days 1-3 and 8-10), for a total of 12 doses with each treatment cycle. AZD1775 should be taken approximately 2 hours before or 2 hours after food. |
Inclusion Criteria: 1. Age ≥18 2. Previous chemotherapy for recurrent or metastatic disease. 3. Measurable disease is required for Part B expansion cohorts according to RECIST v1.1 criteria. 4. Radiation therapy completed at least 7 days prior to start of study treatment and patients must have reco...