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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01625286 | Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients | PHASE1 | COMPLETED | 148 | — | — | Oct 3, 2012 | Oct 3, 2022 | Jan 18, 2023 | 41 | Bulgaria, Canada +9 |
An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting
Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of \>=5mm, or progression of non-target lesions or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| Part A: Intermittent schedule (2/5) | EXPERIMENTAL | See intervention description below. |
| Part A: Intermittent schedule (4/3) | EXPERIMENTAL | See intervention description below. |
| Part B: AZD5363 combined with paclitaxel | ACTIVE_COMPARATOR | See intervention description below. |
| Part B: paclitaxel combined with placebo | PLACEBO_COMPARATOR | See intervention description below. |
| Name | Type | Description |
|---|---|---|
| AZD5363 when combined with weekly paclitaxel. | DRUG | AZD5363: oral capsule, twice daily in a weekly 2 days on-treatment, 5 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles. |
| AZD5363when combined with weekly paclitaxel. | DRUG | Either a 2/5 or 3/4 intermittent dosing schedule of AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles. |
| A placebo in combination with weekly paclitaxel. | DRUG | Either a 2/5 or 3/4 intermittent dosing schedule of placebo matched to AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. placebo and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles. |
Inclusion Criteria: * Provision of informed consent. * Female patient. * Aged at least 18 years. * Histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be ER+ve, HER2-ve, in Part B). * World Health Organisation (WHO) performance status 0-1 ...