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Panobinostat

Phase 1

Multiple Myeloma | Small molecule | Oncology |Amgen Inc.|Last Updated: Jan 16, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Panobinostat · 1 trial · 1 indication

Phase 1 1
NCT01549431Study of the Combination of Panobinostat & Carfilzomib in Patients With Relapsed &/or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED32 Analytics
PHASE1COMPLETED
Study of the Combination of Panobinostat & Carfilzomib in Patients With Relapsed &/or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) of the combination of panobinostat and carfilzomib
28 day cycle
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Combo of Panobinostat and CarfilzomibEXPERIMENTALA cycle of therapy is 4 weeks (28 days in duration). Carfilzomib (with dexamethasone during cycle 1) will be administered intravenously infusion on days 1, 2 and 8, 9 and 15, 16 of every 28 day cycle. Panobinostat is administered orally three times per week.

Interventions

NameTypeDescription
PanobinostatDRUGPanobinostat will be supplied as 5-mg or 20-mg pink/opaque-colored, hard gelatin capsules. Panobinostat is administered orally three times per week. * Standard 3+3 design * 3 out of 4 weeks
CarfilzomibDRUGCarfilzomib in Cycle 1 will be initiated intravenously at 20 mg/m² on Days 1 and 2 and escalated to 27 mg/m² for Days 8, 9, 15, and 16 of Cycle 1 and for the duration of treatment. * Standard 3+3 design * Days 1/2, 8/9 and 15/16 every 4 weeks
DexamethasoneDRUGDexamethasone (4 mg) must be given prior to each carfilzomib infusion during Cycle 1. Dexamethasone pre-dose should continue through Cycle 2 if fever is observed post-dose, Cycle 2 Day 1, or thereafter associated with the infusion of carfilzomib.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Male or female patients aged ≥ 18 years old 2. Diagnosis of multiple myeloma (MM) following at least one prior therapy; there is no maximum number or prior therapies 3. Patients must have relapsed/ refractory disease and be in need of therapy with evidence of measurable disea...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about Panobinostat

What is Panobinostat used for in Multiple Myeloma?

Panobinostat is an investigational small molecule being studied for the treatment of Multiple Myeloma. It is a histone deacetylase inhibitor that is being evaluated in combination with carfilzomib for patients with relapsed and/or refractory Multiple Myeloma. The drug is currently in Phase 1 clinical development.

What does Panobinostat target?

Panobinostat is a histone deacetylase inhibitor. It works by inhibiting histone deacetylase enzymes, which play a role in gene expression and protein activity. This mechanism is being studied for its potential anti-cancer effects in Multiple Myeloma.

Who makes Panobinostat?

Panobinostat is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Multiple Myeloma.

What phase is Panobinostat in?

Panobinostat is currently in Phase 1 clinical development for Multiple Myeloma. It is an investigational drug and has not been approved by the FDA. The ongoing clinical program is evaluating the drug in combination with carfilzomib for patients with relapsed and/or refractory disease.

What clinical trials is Panobinostat in?

Panobinostat is being studied in a Phase 1 clinical trial with the identifier NCT01549431. This completed trial, titled 'Study of the Combination of Panobinostat & Carfilzomib in Patients With Relapsed &/or Refractory Multiple Myeloma,' enrolled 32 participants in the United States. The study was uncontrolled and not randomized or double-blinded.

Is Panobinostat the same as LBH589?

Panobinostat is also known as LBH589. This alternative name is used in some clinical and scientific contexts to refer to the same drug. Both names refer to the histone deacetylase inhibitor being developed by Amgen Inc. for the treatment of Multiple Myeloma.