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Tanespimycin

Phase 3

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

Tanespimycin development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Aug 2007

Tanespimycin target and mechanism

Molecular targetHSP90AA1, HSP90AB1
Target classInhibitor
ModalitySmall molecule

Also known as BMS-722782

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials4
Total Enrollment84

FDA Designations

No designations recorded

Tanespimycin clinical trials

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 338 trials

Frequently asked questions about Tanespimycin

What is tanespimycin used for?

Tanespimycin is an investigational oncology drug studied in advanced malignancies, multiple myeloma, and solid tumors. It has been evaluated in patients with relapsed or refractory multiple myeloma and in solid tumors, including HER2 positive metastatic breast cancer that had previously failed trastuzumab. It is not an approved therapy.

What does tanespimycin target?

Tanespimycin targets HSP90AA1 and HSP90AB1, the alpha and beta isoforms of heat shock protein 90. It acts as an HSP90 inhibitor. By binding these chaperone proteins, tanespimycin interferes with the folding and stability of client proteins that cancer cells depend on for growth and survival.

Who is developing tanespimycin?

Tanespimycin was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The compound is also known by the code KOS-953, reflecting its earlier development history before Bristol-Myers Squibb advanced it in oncology clinical programs.

What phase is tanespimycin in?

Tanespimycin is an investigational agent that has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. It is not FDA approved. The completed studies enrolled a total of 53 patients across advanced malignancies, multiple myeloma, and solid tumors, and no trials are currently active.

What clinical trials is tanespimycin in?

Completed tanespimycin trials include NCT00546780, a Phase 3 study in multiple myeloma in first relapse, and NCT00514371, a Phase 2 study in relapsed-refractory multiple myeloma. NCT00773344 tested tanespimycin with trastuzumab in solid tumors and HER2 positive metastatic breast cancer, and NCT00779428 was a Phase 2 continuing-treatment study in advanced malignancies.

Is tanespimycin the same as KOS-953?

Yes. Tanespimycin and KOS-953 refer to the same investigational compound. KOS-953 was the earlier development code used in trial titles such as the Phase 3 multiple myeloma study and the Phase 2 relapsed-refractory multiple myeloma study. Both names identify the same HSP90 inhibitor developed by Bristol-Myers Squibb.