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AZD8186 monotherapy · 1 trial · 3 indications
Assess safety and tolerability of AZD8186 when given as monotherapy or in combination with abiraterone acetate (with prednisone) or with AZD2014 by measuring AEs, SAE (incl death), safety measures incl ECG, physical exam, pulse, blood pressure, weight, lab variables
| Arm | Type | Description |
|---|---|---|
| Part A: AZD8186 monotherapy | EXPERIMENTAL | Patients will receive a single dose on Day 1 followed by ongoing multiple dosing. The initial schedule will use intermittent dosing of AZD8186. |
| Part C2: AZD8186/abiraterone | EXPERIMENTAL | Patients will receive a week of abiraterone acetate with prednisone followed by combination dosing with AZD8186. |
| Part D1: AZD8186 and AZD2014 | EXPERIMENTAL | Combination dosing with AZD8186 and AZD2014 both given on an intermittent schedule at escalating dose levels of each IMP for combination dose finding |
| Part B: AZD8186 monotherapy | EXPERIMENTAL | Part B - multiple dosing of intermittent dose schedule |
| Part D2: AZD8186/ AZD2014 | EXPERIMENTAL | Expanded cohort of patients will be treated at a tolerated combination dose level established in Part D1 |
| Part C1: AZD8186 & abiraterone | EXPERIMENTAL | Patients will receive a week of abiraterone acetate with prednisone followed by combination dosing with AZD8186 at escalating doses of AZD8186 for the purpose of dose finding |
| Name | Type | Description |
|---|---|---|
| Part A: AZD8186 monotherapy | DRUG | The initial schedule will use intermittent dosing of AZD8186. Dose, frequency and schedule in subsequent cohorts may be modified in response to safety, tolerability, pharmacokinetic and preclinical data. |
| Part B: AZD8186 monotherapy | DRUG | Part B will be at a dose(s) and schedule(s) at or below from Part A |
| Part C1: Abiraterone acetate combination with AZD8186 | DRUG | Dose and schedule finding of AZD8186 added to approved labelled dose of abiraterone acetate (with prednisone). |
| Part D1: AZD2014 combination with AZD8186 | DRUG | Dose \& schedule finding of AZD8186 in combination with AZD2014 |
| Part D2 AZD2014 combination with AZD8186 | DRUG | Combination AZD8186/ AZD2014 dose expansion at dose determined in Part D1 |
| Part C2: Abiraterone acetate combination with AZD8186 | DRUG | Dose expansion of AZD8186 at dose determined in Part C1 added to approved dose of abiraterone acetate (with prednisone) |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Male or female, aged 18 years and older * Histologically or cytologically proven diagnosis of prostate cancer, sqNSCLC, TNBC, or known PTEN-deficient solid malignancy, and is refra...
AZD8186 monotherapy is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for advanced castrate-resistant prostate cancer (CRPC). It is also studied in squamous non-small cell lung cancer and triple negative breast cancer. It is a Phase 1 agent and has not been approved for any indication.
AZD8186 monotherapy targets PIK3CB and PIK3CD, which are isoforms of phosphoinositide 3-kinase. It is classified as an inhibitor of these targets. By inhibiting PIK3CB and PIK3CD, the drug is designed to interfere with PI3K signaling in tumor cells.
AZD8186 monotherapy is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this small molecule in advanced castrate-resistant prostate cancer and other solid tumors.
AZD8186 monotherapy is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 program has completed, with one completed trial and no active trials listed.
AZD8186 monotherapy was evaluated in the Phase 1 trial NCT01884285, titled AZD8186 First Time In Patient Ascending Dose Study. This completed trial enrolled 147 patients across the United States, Canada, Spain, and the United Kingdom, and included advanced castrate-resistant prostate cancer, squamous non-small cell lung cancer, and triple negative breast cancer.
Yes. AZD8186 monotherapy is also referred to as Part A: AZD8186 monotherapy and Part B: AZD8186 monotherapy. These names refer to the same investigational agent developed by AstraZeneca PLC for advanced castrate-resistant prostate cancer and related solid tumors.