Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PIM447 · 1 trial · 1 indication
To estimate the maximum tolerated dose and/or recommended dose for expansion for each of the following three treatment arms in patients with myelofibrosis (MF): PIM447 plus ruxolitinib (doublet), LEE011 plus ruxolitinib (doublet), PIM447 plus ruxolitinib and LEE 011 (triple combination).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm 1 | EXPERIMENTAL | - |
| Dose Escalation Arm 2 | EXPERIMENTAL | - |
| Dose Escalation Arm 3 | EXPERIMENTAL | - |
| Dose Expansion Arm 1 | EXPERIMENTAL | - |
| Dose Expansion Arm 2 | EXPERIMENTAL | - |
| Dose Expansion Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PIM447 | DRUG | pan-pim inhibitor |
| Ruxolitinib | DRUG | JAK1/JAK2 inhibitor |
| LEE011 | DRUG | CDK4/6 inhibitor |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Patient must be diagnosed with JAK2V617F-positive primary or secondary MF. * Dose-escalation and Expansion parts: Patients with a \< 35% reduction in spleen volume by MRI/CT or \< 50% reduction in spleen si...
PIM447 is an investigational small molecule being studied for the treatment of myelofibrosis. It is a targeted therapy that has been evaluated in a Phase 1 clinical trial in combination with other agents. The drug is not approved and remains in clinical development for this condition.
PIM447 is a small molecule that targets PIM kinases, which are enzymes involved in cell survival and proliferation. By inhibiting these kinases, the drug aims to interfere with cancer cell growth. This mechanism is being explored in the context of myelofibrosis, a type of bone marrow disorder.
PIM447 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with myelofibrosis.
PIM447 is in Phase 1 clinical development. A Phase 1 study has been completed to assess the safety of PIM447 when used in combination with other drugs for myelofibrosis. The drug is investigational and has not received regulatory approval for any indication.
PIM447 has been studied in one clinical trial, identified as NCT02370706. This was a Phase 1 study titled 'Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis.' The trial enrolled 15 participants and has been completed.
PIM447 is a distinct investigational compound developed by Novartis. It is not known to have alternative names or be identical to other approved drugs. In clinical trials, it has been studied in combination with ruxolitinib and LEE011, but it is a separate therapeutic agent.