Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8931 · 6 trials · 6 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 |
|---|---|---|
| 40 mg AZD8931 wet granulation tablet formulation | ACTIVE_COMPARATOR | - |
| 40 mg AZD8931 roller compacted tablet formulation | EXPERIMENTAL | - |
| AZD8931 | EXPERIMENTAL | \[14C\] AZD8931 |
| 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 | 40 mg AZD8931 wet granulation tablet formulation |
| [14C] AZD8931 | DRUG | Single 160 mg oral dose administered on Day 1 |
| Paclitaxel | DRUG | IV once weekly for 3 weeks followed by a week off |
| Placebo | DRUG | Oral bid (twice daily) |
Inclusion Criteria: * Male or female subjects aged 18 to 55 years * Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential * Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more...
AZD8931 is an investigational small molecule being studied for the treatment of advanced solid malignancies, including breast cancer and metastatic cancer. It has been evaluated in Phase 1 clinical trials in patients with these conditions, as well as in healthy volunteers for absorption, distribution, metabolism, and excretion studies.
AZD8931 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials of AZD8931 in multiple countries, including Germany, Russia, Japan, and the United Kingdom.
AZD8931 is in Phase 1 clinical development. All three completed trials of AZD8931 were Phase 1 studies, and none of these trials are currently active. The drug remains investigational and has not been approved by regulatory authorities for any use.
AZD8931 has been studied in three completed clinical trials: NCT00637039 in patients with advanced solid malignancies, NCT00900627 in advanced solid tumors and breast cancer, and NCT01003158 in Japanese patients with metastatic or breast cancer. A fourth trial, NCT01284595, studied the drug in healthy male volunteers.
AZD8931 is a distinct investigational drug developed by AstraZeneca. It has been studied alone and in combination with paclitaxel in clinical trials for advanced solid tumors and breast cancer. No alternative names for AZD8931 have been reported in the clinical trial records.