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Panobinostat/LBH589 · 1 trial · 2 indications
Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simon's optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B.
| Arm | Type | Description |
|---|---|---|
| Stratum A | EXPERIMENTAL | patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week. |
| Stratum B | EXPERIMENTAL | patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week. |
| Name | Type | Description |
|---|---|---|
| Panobinostat/LBH589 | DRUG | - |
Inclusion Criteria: * Written informed consent prior to study-specific screening procedures * Life expectancy of ≥ 60 days * Eastern Cooperative Group (ECOG) performance status ≤ 2 * Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed i...
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Panobinostat is an investigational small molecule being studied for multiple oncology indications, including multiple myeloma in relapse, myelodysplastic syndromes (MDS), refractory leukemia, mantle cell lymphoma, prostate cancer, and Hodgkin's lymphoma. It is currently in Phase 1 clinical development and is not approved by the FDA.
Panobinostat is being developed by Novartis AG, which trades under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types, including Hodgkin's lymphoma and multiple myeloma.
Panobinostat is currently in Phase 1 clinical development. While some completed trials have explored Phase 2 and Phase 3 settings, the drug's overall development stage is Phase 1, and it remains investigational, not approved for any indication.
Panobinostat has been studied in several completed trials, including NCT00742027 for relapsed/refractory classical Hodgkin's lymphoma, NCT01034163 for maintenance in Hodgkin's lymphoma, NCT01083602 for relapsed and bortezomib-refractory multiple myeloma, and NCT01504776 for mantle cell lymphoma. All trials are completed.
Panobinostat is also known by the alternative name LBH589. This alternative name may appear in clinical trial registries and scientific literature, referring to the same investigational drug being developed by Novartis for oncology indications.
Panobinostat is a small molecule that targets histone deacetylases (HDACs), enzymes involved in gene expression regulation. By inhibiting HDAC activity, it may alter cancer cell growth and survival pathways. However, specific molecular targets have not been detailed in the available information.