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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03313557 | AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies | PHASE1 | COMPLETED | 48 | — | — | Oct 27, 2017 | May 17, 2019 | Jun 24, 2019 | 14 | United States, France +2 |
To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours. If new or aggravated physical findings imply deterioration compared with baseline, the finding will be reported as an Adverse Event, unless the findings are unequivocally due to disease progression.
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours.
To assess the safety and tolerability of AZD1775 printed capsules following oral dosing in patients with advanced solid tumours; deterioration of haematology and clinical chemistry laboratory values as compared to baseline will be reported as Adverse Events if they fulfill any of the Serious Adverse Events criteria or are the reason for discontinuation of the study treatment unless clearly due to the progression of disease under study; if deterioration in a laboratory value is associated with clinical signs and symptoms, the sign or symptom will be reported as an AE and the associated laboratory result will be considered as additional information.
| Arm | Type | Description |
|---|---|---|
| Wee-1 kinase inhibitor AZD1775 | EXPERIMENTAL | To assess the safety of AZD1775 following oral dosing of the capsule formulation in patients with advanced solid tumours in patients who have previously completed 1 of the AZD1775 clinical pharmacology studies and not have met any requirements to permanently discontinue treatment with AZD1775. |
| Name | Type | Description |
|---|---|---|
| Wee-1 kinase inhibitor AZD1775 | DRUG | Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated. |
Inclusion Criteria: For inclusion in this study, patients must fulfil the following criteria: * Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures. * Female or male aged ≥18 years. * Has completed 1 of the parent AZD1775 cl...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |