Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C] AZD8931
AZD8931 · 3 trials · 5 indications
DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval \> 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)
| Arm | Type | Description |
|---|---|---|
| Monotherapy part | EXPERIMENTAL | AZD8931 monotherapy |
| Combination part | EXPERIMENTAL | AZD8931 plus paclitaxel |
| 1 | EXPERIMENTAL | AZD8931 plus Paclitaxel |
| 2 | PLACEBO_COMPARATOR | Placebo plus Paclitaxel |
| Name | Type | Description |
|---|---|---|
| AZD8931 | DRUG | Tablet Oral bid |
| Paclitaxel | DRUG | IV once weekly for 3 weeks followed by a week off |
| Placebo | DRUG | Oral bid (twice daily) |
Inclusion Criteria: * Cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part) * Patients suitable for Paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part) * Life expectancy more than 12 weeks ...
AZD8931 is an investigational small molecule developed by AstraZeneca PLC for advanced solid malignancies and neoplasms, including breast cancer. It has been studied in Phase 1 clinical trials, both as a single agent and in combination with paclitaxel. It is not an approved therapy and remains in clinical development.
AZD8931 targets HER2, a receptor tyrosine kinase involved in cancer cell growth signaling. By acting on HER2, the small molecule is designed to interfere with signaling pathways that drive tumor proliferation. This mechanism underlies its investigation in advanced solid malignancies and breast cancer.
AstraZeneca PLC develops AZD8931. The company trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 1 clinical trials evaluating the compound in advanced solid malignancies and breast cancer.
AZD8931 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. All reported trials of AZD8931 are Phase 1 studies, and no active trials are currently listed.
AZD8931 has been evaluated in completed Phase 1 trials, including NCT01003158 in Japanese patients with neoplasms and breast cancer, NCT00900627 with paclitaxel in advanced solid tumors and breast cancer, and NCT00637039 in advanced solid malignancies. Total enrollment across these studies was 347 patients.
Yes, [14C] AZD8931 is an alternative name for AZD8931. The carbon-14 labeled form refers to the same AstraZeneca compound studied in Phase 1 trials for advanced solid malignancies and neoplasms. Readers searching either name are looking at the same investigational agent.