Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8835 · 1 trial · 3 indications
MTD - A dose will be considered non-tolerated and dose escalation will stop if 2 or more of up to 6 evaluable patients experience a dose limiting toxicity at a dose level. Once the non-tolerated dose is defined, the MTD will be confirmed at the previous dose level below the non-tolerated dose or a dose between the non-tolerated dose and the last tolerated dose my be investigated. A minimum of 6 evaluable patients are required to determine the MTD. Recommended Phase II dose - A minimum of 6 evaluable patients is necessary to determine the recommended dose. A dose will be considered non-tolerated and dose escalation will stop if 2 or more patients experience a dose dose limiting toxicity at a dose level.
Assessed in terms of adverse events and laboratory data that is collected on all patients
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | AZD8835 single agent dose escalation |
| Part B | EXPERIMENTAL | Following the single agent dose escalation (Part A), additional patients with mutations in the PIK3CA gene will be enrolled to a single agent dose expansion phase at the MTD or recommended phase II dose (RP2D) at the selected dose schedule (as appropriate) to explore further the safety, tolerability, pharmacokinetics and biological activity at the selected dose (Part B). Part B will include patients with ER+/HER2 negative breast cancer whose tumours have a mutation of the PIK3CA gene and patients with any solid tumours which have a mutation of the PIK3CA gene. |
| Part C | EXPERIMENTAL | AZD8835 in combination with fulvestrant dose escalation |
| Part D | EXPERIMENTAL | Following the combination dose escalation segment of the study (Part C), additional postmenopausal patients with ER+/HER negative breast cancer and mutations of the PIK3CA gene will be enrolled to a AZD8835 and fulvestrant combination dose expansion phase at the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (as appropriate) to explore further the safety, tolerability, pharmacokinetics and biological activity at the selected dose (Part D). |
| Name | Type | Description |
|---|---|---|
| AZD8835 | DRUG | AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components |
| AZD8835 in combination with fulvestrant | DRUG | AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components. Fulvestrant is approved for the treatment of postmenopausal women with ER+ locally advanced or metastatic breast cancer following progression of disease while receiving anti-estrogen therapy. |
Inclusion Criteria: 1. Part A: Histological or cytological confirmation of a solid tumor and disease progression. Part B: Histological or cytological confirmation of ER positive, HER2 negative breast cancer and disease progression or any other solid tumor with a PIK3CA gene mutation. Part C: Histol...
AZD8835 is an investigational small molecule being studied for the treatment of advanced solid malignancies, including ER-positive, HER2-negative breast cancer and tumors with PIK3CA gene mutations. It is being developed by AstraZeneca PLC and has been evaluated in a Phase 1 clinical trial.
AZD8835 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical trial evaluating the compound in patients with advanced solid tumors.
AZD8835 is in Phase 1 clinical development. It has completed one Phase 1 dose study in patients with advanced solid malignancies. The drug is investigational and has not been approved by the FDA for any indication.
AZD8835 has been evaluated in one Phase 1 clinical trial, NCT02260661, titled a Phase I dose study of the safety and pharmacokinetics of AZD8835 in patients with advanced solid tumors. The trial enrolled 20 patients across the United States and the United Kingdom and is now completed.
AZD8835 is a small molecule studied in tumors with PIK3CA gene mutations, and the Phase 1 trial enrolled patients with ER-positive, HER2-negative breast cancer and PIK3CA-mutated advanced solid malignancies. The study was biomarker-selected, enrolling patients based on PIK3CA mutation status.