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AZD9496 · 3 trials · 3 indications
Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. ER expression
To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.
To evaluate the area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC (0-t) of AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation
To evaluate maximum plasma concentration (Cmax) of capsule variants by comparing with reference AZD9496
To evaluate area under curve from time zero to time with last observation (AUC0-t) of variants by comparing with reference AZD9496
To evaluate area under the curve from time zero to time infinity (AUC 0-infinity) of variants by comparing with reference AZD9496
To evaluate area under the curve from time zero to infinity (AUC 0-infinity) for AZD9496 and its metabolites
Safety and tolerability in terms of adverse events, serious adverse events (including death) and safety measures: ECG, physical examination, vital signs and laboratory variables. Definition of maximum tolerated dose (MTD) or maximum feasible dose (MFD) by measuring the number of evaluable patients with dose-limiting toxicities.Time frame DLT period 28 days
| Arm | Type | Description |
|---|---|---|
| Standard arm | ACTIVE_COMPARATOR | Fulvestrant, 500 mg |
| AZD9496 | EXPERIMENTAL | 250 mg bd taken orally for 5-14 days |
| Name | Type | Description |
|---|---|---|
| Standard Arm - Fulvestrant | DRUG | 500 mg Fulvestrant administered as two consecutive 5 ml intramuscular injections on Day 1, one in each buttock |
| AZD9496 | DRUG | Administered at 250 mg bd orally for 5-14 days commencing on Day 1, and continuing up to the day of biopsy |
| AZD9496 (Reference) | DRUG | AZD9496 (Reference) |
| AZD9496 Variant A | DRUG | AZD9496 Variant A. |
| AZD9496 Variant B | DRUG | AZD9496 Variant B |
| AZD9496 Variant C | DRUG | AZD9496 Variant C |
| AZD9496 Variant D | DRUG | AZD9496 Variant D |
Inclusion criteria: 1. Signed and dated informed consent form (ICF) 2. Women \>=18 years 3. Patients with newly diagnosed resectable primary breast cancer scheduled to undergo treatment with curative intent by surgery 4. Histologically confirmed invasive breast cancer involving a palpable tumor of ...
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AZD9496 is an investigational small molecule being studied for the treatment of breast cancer, specifically in postmenopausal women with ER+ HER2- primary breast cancer and in ER+ HER2- advanced breast cancer. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 1 clinical development.
AZD9496 is an oral small molecule that targets and degrades the estrogen receptor (ER). It is being studied in ER+ HER2- breast cancer, where it aims to block estrogen receptor signaling. The drug is designed to be given orally and is being evaluated in postmenopausal women.
AZD9496 is being developed by AstraZeneca PLC, a global biopharmaceutical company. AstraZeneca's stock ticker is AZN. The drug is currently in Phase 1 clinical trials for the treatment of ER+ HER2- breast cancer.
AZD9496 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All clinical trials for AZD9496 have been completed, and it is not currently in active trials.
AZD9496 has been studied in three completed Phase 1 clinical trials. NCT02248090 was a first-in-patient ascending dose study in ER+ HER2- advanced breast cancer. NCT02780713 assessed pharmacokinetics and safety in healthy subjects. NCT03236974 compared AZD9496 to fulvestrant in postmenopausal women with ER+ HER2- primary breast cancer.
No, AZD9496 is not the same as fulvestrant. AZD9496 is an investigational oral small molecule that degrades the estrogen receptor, while fulvestrant is an approved injectable estrogen receptor antagonist. They were compared in a Phase 1 clinical trial (NCT03236974) in postmenopausal women with ER+ HER2- primary breast cancer.