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panobinostat/LBH589B

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

panobinostat/LBH589B · 2 trials · 2 indications

Phase 1 2
NCT01463046Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic SyndromeAcute Myeloid Leukemia
COMPLETED29 Analytics
NCT01055483A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid LeukemiaAcute Myeloid Leukemia
COMPLETED59 Analytics
PHASE1COMPLETED
Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Acute Myeloid LeukemiaUnlock trial analytics
PHASE1COMPLETED
A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

The maximum tolerated dose (MTD) for the combination of panobinostat with standard-dose cytarabine and daunorubicin (7+3) for untreated AML and advanced MDS in the elderly.
Start of induction therapy until 21 days after the last dose of induction or second induction therapy or until count recovery in patients without residual disease, whichever is longer
The recommended Phase II dose for the combination of panobinostat with standard-dose cytarabine and daunorubicin (7+3) for untreated AML and advanced MDS in the elderly.
Start of induction therapy until 21 days after the last dose of induction or second induction therapy or until count recovery in patients without residual disease, whichever is longer
Incidence of dose limiting toxicity (DLT)
1 cycle (1 cycle = 28 days)

Secondary Endpoints

Response rate (OR, CR, CRi) for AML using Revised Recommendations of the International Working Group
18 days after the start of induction therapy or 37 days after the second induction therapy or when white blood cell count recovers, whichever is first.
Response rate (OR, CR, CRi) for AMS using International Working Group response criteria in myelodysplasia
18 days after the start of induction therapy or 37 days after the second induction therapy or when white blood cell count recovers, whichever is first.
Relapse-free survival
The time to relapse or death from any cause from the date of confirmed morphologic CR.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PanobinostatEXPERIMENTAL -
LBH589EXPERIMENTAL -

Interventions

NameTypeDescription
PanobinostatDRUGInduction - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8 Second induction - 20-60 mg (1-3 20 mg capsules) PO days 1,3 and 5 Consolidation - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8
CytarabineDRUGInduction - 100 mg/m2 continuous IV daily for 7 doses on day 3-9. Second induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-7. Dosing for consolidation - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.
DaunorubicinDRUGInduction - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5. Second induction - 60 mg/m2 IV over 15-30 minutes daily for 2 doses on day 3 and 4. Dosing for consolidation - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.
panobinostat/LBH589BDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Untreated histologically confirmed acute myeloid leukemia OR advanced myelodysplastic syndrome (INT-2 or High risk) not previously treated with anthracycline-based chemotherapy OR a therapy-related myeloid neoplasm * Male or female aged ≥ 60 years * ECOG performance status 0-2...

Countries:United StatesFranceGermany
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Frequently asked questions about panobinostat/LBH589B

What is Panobinostat used for?

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.

Who makes Panobinostat?

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.

What phase is Panobinostat in?

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.

What clinical trials is Panobinostat in?

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.

Is Panobinostat the same as LBH589?

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.

How does Panobinostat work?

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.