Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Part C - AZD6094 monotherapy (Japan only), Part C- AZD6094 monotherapy
AZD6094 · 2 trials · 2 indications
The primary outcome measure was Objective Response Rate (ORR), defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to Response Evaluation Criteria for Solid Tumours (RECIST) v1.1.
The primary outcome measure was ORR, defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to RECIST v1.1.
The primary outcome measure was ORR, defined as the proportion of patients with either a confirmed complete response/partial response by investigator assessment according to RECIST v1.1.
To assess the effect of AZD6094 at single therapeutic dose (600mg) on ventricular repolarization by assessing the time matched baseline-adjusted, placebo subtracted QTc interval corrected for RR (R waves on electrocardiogram \[ECG\]) by the Fridericia formula (QTcF). The ECGs -digital (dECG) and page (pECG) would be recorded during the study for the assessment of safety. Paper ECG for safety review will be performed following the dECG recordings and at additional intervals if required.
| Arm | Type | Description |
|---|---|---|
| AZD6094 600 mg daily continuously | EXPERIMENTAL | All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously. |
| Cohort 1 | EXPERIMENTAL | Participants will receive orally single dose of study drugs in the sequence of ABC. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg |
| Cohort 2 | EXPERIMENTAL | Participants will receive orally single dose of study drugs in the sequence of ACB. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg |
| Cohort 3 | EXPERIMENTAL | Participants will receive orally single dose of study drugs in the sequence of BAC. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg |
| Cohort 4 | EXPERIMENTAL | Participants will receive orally single dose of study drugs in the sequence of BCA. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg |
| Cohort 5 | EXPERIMENTAL | Participants will receive orally single dose of study drugs in the sequence of CAB. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg |
| Cohort 6 | EXPERIMENTAL | Participants will receive orally single dose of study drugs in the sequence of CBA. A - AZD6094 600 mg (3X 200 mg tablet) B - Placebo C - Moxifloxacin 400 mg |
| Name | Type | Description |
|---|---|---|
| AZD6094 | DRUG | AZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor. |
| AZD6094 200 mg | DRUG | A potent and selective small molecule mesenchymal epithelial transition (MET) kinase inhibitor with significant antitumor activity. |
| Placebo | OTHER | AZD6094 matching placebo without any pharmacological activity. |
| Moxifloxacin | DRUG | A fluoroquinolone broad-spectrum antibiotic, produces a mild, but reproducible increase in QT interval corrected (QTc) in healthy normal participants at time to reach maximum concentration (tmax - approximately 2 hours (0.5 to 4 hours)). This effect is close to the ECG interval measured from the onset of the QRS complex (onset of the QRS complex to the J point) to the offset of the T wave (QT)/QTc effect that represents the threshold of regulatory concern, around 5 ms mean QTc interval prolongation. |
Inclusion criteria 1. Provision of informed consent prior to any study specific procedures, sampling and analyses. 2. Histologically confirmed PRCC, which is locally advanced or metastatic. 3. Availability of an archival tumor sample or a pre-treatment fresh tumor sample for confirmation of PRCC by...
AZD6094 is an investigational small molecule being studied for the treatment of papillary renal cell cancer and solid tumors. It is being developed by AstraZeneca PLC (AZN) and has been evaluated in clinical trials for these oncology indications.
AZD6094 is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not described here.
AZD6094 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is an investigational small molecule in clinical development for oncology indications.
AZD6094 has completed a Phase 2 clinical trial for papillary renal cell cancer. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study in healthy volunteers has also been completed.
AZD6094 has been studied in two completed clinical trials. NCT02127710 was a Phase 2 trial in patients with papillary renal cell carcinoma, enrolling 111 participants across the United States, Canada, Spain, and the United Kingdom. NCT03258515 was a Phase 1 study in healthy male volunteers.
Yes, AZD6094 is also known as HMPL-504. The Phase 2 clinical trial for papillary renal cell carcinoma, NCT02127710, refers to the drug as AZD6094 (HMPL-504) in its title.