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 ...
Top 20 of 87 competitors
AZD5363 when combined with weekly paclitaxel is an investigational small molecule therapy studied in advanced or metastatic breast cancer. The combination pairs AZD5363 with weekly paclitaxel chemotherapy. It has been evaluated in a Phase 1 clinical trial that is now completed, with 148 patients enrolled.
AZD5363 when combined with weekly paclitaxel is being studied for advanced or metastatic breast cancer, including ER-positive advanced or metastatic breast cancer. The trial enrolled adult women with these conditions. It is an investigational combination and is not approved for use.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD5363 when combined with weekly paclitaxel. The company sponsored the clinical trial evaluating this combination in breast cancer patients.
AZD5363 when combined with weekly paclitaxel is in Phase 1 development. The single trial evaluating this combination has been completed. It is an investigational therapy and has not been approved by the FDA.
AZD5363 when combined with weekly paclitaxel was evaluated in the Phase 1 trial NCT01625286, titled Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients. The trial is completed and enrolled 148 participants across multiple countries.
AZD5363 when combined with weekly paclitaxel refers to the investigational combination of the small molecule AZD5363 with weekly paclitaxel chemotherapy. AZD5363 alone is a separate agent, and the combination is studied specifically in advanced or metastatic breast cancer.