Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glasdegib · 1 trial · 2 indications
This is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.
| Arm | Type | Description |
|---|---|---|
| CPX-351 and Glasdegib | EXPERIMENTAL | In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28. If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28. In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28. If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year |
| Name | Type | Description |
|---|---|---|
| Glasdegib | DRUG | Given PO |
| CPX-351 | DRUG | Given IV |
Inclusion Criteria: * Previously untreated therapy-related AML or AML with myelodysplastic related changes as described by World Health Organization (WHO) 2016 1. AML arising in MDS (including CMML) or MDS/MPN syndrome 2. AML with MDS-related cytogenetic abnormalities (Appendix A, metaphase FI...
Glasdegib is an investigational small molecule being studied for Acute Myelogenous Leukemia (AML) Due to Therapy. It is also being evaluated in Acute Myeloid Leukemia With Myelodysplasia-Related Changes. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
Glasdegib targets the Hedgehog signaling pathway, as indicated by its -degib (Hedgehog) target class. It is a small molecule designed to interfere with this pathway, which is implicated in certain cancers. The drug is being studied in combination with CPX-351 for specific types of acute myeloid leukemia.
Glasdegib is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with acute myeloid leukemia.
Glasdegib is in Phase 2 clinical development. It is currently being studied in an active, not recruiting clinical trial for Acute Myelogenous Leukemia (AML) Due to Therapy and Acute Myeloid Leukemia With Myelodysplasia-Related Changes. The drug is investigational and not yet approved.
Glasdegib is being evaluated in clinical trial NCT04231851, titled 'CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia'. This Phase 2 trial is active but not recruiting, with an enrollment of 30 participants in the United States.
No, Glasdegib is not the same as CPX-351. Glasdegib is a small molecule targeting the Hedgehog pathway, while CPX-351 is a liposomal formulation of chemotherapy drugs. The two are being studied in combination in clinical trial NCT04231851 for acute myeloid leukemia.