Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIDAZA · 1 trial · 1 indication
DLT (MEDI4736 monotherapy only) assessment will be done by reviewing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. For monotherapy or combo w/aza AEs, SAEs, lab evaluations, vital signs, physical exams, ECGs will be done.
Overall safety assessments will be done by reviewing adverse events (AEs, serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations and electrocardiogram (ECG) results.
| Arm | Type | Description |
|---|---|---|
| MEDI4736 Evaluate MEDI4736 in MDS | EXPERIMENTAL | Evaluate MEDI4736 monotherapy and MEDI4736 in combination with azacitidine after monotherapy progression in MDS |
| MEDI4736 + tremelimumab | EXPERIMENTAL | Evaluate MEDI4736 in combination with tremelimumab |
| MEDI4736 + tremelimumab + azacitidine | EXPERIMENTAL | Evaluate MEDI4736 in combination with tremelimumab and azacitidine |
| Name | Type | Description |
|---|---|---|
| MEDI4736 Evaluate MEDI4736 in MDS | BIOLOGICAL | MEDI4736 will be administered by IV infusion |
| VIDAZA | DRUG | VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy |
| tremelimumab | BIOLOGICAL | tremelimumab will be administered by IV infusion |
Inclusion Criteria: Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function. Exclusion Criteria: Concurren...
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VIDAZA is used for Myelodysplastic Syndrome, a type of blood cancer. It is being studied as a treatment for this condition in clinical trials. The drug is currently in Phase 1 development for this indication.
VIDAZA is developed by AstraZeneca PLC, a biopharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug for Myelodysplastic Syndrome.
VIDAZA is in Phase 1 clinical development for Myelodysplastic Syndrome. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
VIDAZA has been studied in one clinical trial with the identifier NCT02117219. This was a Phase 1 study to evaluate the drug in subjects with Myelodysplastic Syndrome. The trial was completed and enrolled 67 participants across the United States, France, Germany, and the United Kingdom.
VIDAZA is the drug name used in the clinical trial NCT02117219, which is titled 'Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome.' The trial evaluates MEDI4736, and VIDAZA may be the brand name or an alternative name for this investigational drug.