Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5363 when combined with weekly paclitaxel · 1 trial · 2 indications
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 ...
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AZD5363 is an investigational small molecule being studied in combination with weekly paclitaxel for the treatment of advanced or metastatic breast cancer, including ER-positive advanced or metastatic breast cancer. It is being evaluated in a Phase 1 clinical trial to assess its safety, tolerability, and efficacy in this patient population.
AZD5363 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research to evaluate the drug's potential in treating advanced or metastatic breast cancer when combined with paclitaxel.
AZD5363 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial evaluating AZD5363 in combination with paclitaxel has been completed.
AZD5363 is being studied in clinical trial NCT01625286, titled 'Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients.' This Phase 1 trial enrolled 148 female participants aged 18 years and older across multiple countries, including Bulgaria, Canada, Czechia, France, Japan, Mexico, Peru, Singapore, South Korea, Spain, and the United Kingdom.
AZD5363 is also known by the name capivasertib. It is an investigational small molecule being developed by AstraZeneca for the treatment of advanced or metastatic breast cancer. The drug is being studied in combination with paclitaxel in a completed Phase 1 clinical trial.