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tanespimycin

Phase 3

Multiple Myeloma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 7, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

tanespimycin · 4 trials · 4 indications

Phase 3 1Phase 2 2Phase 1 1
NCT00546780A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First RelapseMultiple Myeloma
COMPLETED31 Analytics
PHASE3COMPLETED
A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival
6-24 months
Objective Response Rate
approximately 3 months
There is no Primary Outcome
No formal analysis of efficacy will occur
Objective tumor response rate (RECIST complete response, or partial response ) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)

Secondary Endpoints

Overall survival in each arm of the study
Up to 24 months
Response rate between treatment arms and time-to-event endpoints.
Up to 24 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
3-6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AACTIVE_COMPARATORTanespimycin + Bortezomib
Arm BACTIVE_COMPARATORBortezomib
tanespimycin and bortezomibEXPERIMENTALA patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
bortezomib and tanespimycinEXPERIMENTALA patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
bortezomib tanespimycinEXPERIMENTALA patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
A1EXPERIMENTAL -

Interventions

NameTypeDescription
TanespimycinDRUGSolution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
BortezomibDRUGSolution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Good Performance Status * Documented evidence of multiple myeloma * Documented progression of disease after initial response to one line of therapy * Measurable disease (serum M-protein \>.5g/dl or \> 200 mg urinary M protein excretion) Exclusion Criteria: * Prior treatment ...

Countries:United StatesCanada
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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 tanespimycin

What is Tanespimycin used for?

Tanespimycin is an investigational small molecule being studied for the treatment of solid tumors, advanced malignancies, and multiple myeloma. It has been evaluated in clinical trials for patients with relapsed or refractory multiple myeloma and for solid tumors, including HER2 positive metastatic breast cancer.

Who makes Tanespimycin?

Tanespimycin is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has sponsored clinical trials of the drug in patients with multiple myeloma and solid tumors.

What phase is Tanespimycin in?

Tanespimycin has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. However, it is not approved by the FDA and remains an investigational agent. All completed trials have finished, and there are no active trials currently listed.

What clinical trials is Tanespimycin in?

Tanespimycin has been studied in several completed trials, including NCT00514371 in relapsed or refractory multiple myeloma, NCT00546780 in first relapse multiple myeloma, NCT00773344 in solid tumors and HER2 positive metastatic breast cancer, and NCT00779428 as a continuation study for advanced malignancies.

Is Tanespimycin the same as KOS-953?

Yes, Tanespimycin is also known as KOS-953. Clinical trial titles refer to the drug as Tanespimycin (KOS-953), confirming that these names refer to the same investigational agent.