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Alvespimycin

Phase 2

Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Jun 27, 2011

Alvespimycin development status

Highest phase Phase 2 (NCT00780000)
Phase scored for BMYPhase 1
Registered trials 2 across 1 sponsor since Oct 2008

Alvespimycin target and mechanism

Molecular targetHSP90AA1, HSP90AB1
Target classInhibitor
ModalitySmall molecule

Also known as BMS-826476

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Alvespimycin clinical trials

Alvespimycin · 1 trial · 2 indications

Phase 1 1
NCT00803556Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab TherapySolid Tumor
COMPLETED29 Analytics
PHASE1COMPLETED
Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab Therapy
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Dose Limiting Toxicities
During Cycle 1 (4-weeks in duration)

Secondary Endpoints

Summary of Adverse Events, Serious Adverse Events, Deaths and Discontinuations due to Adverse Events
Weekly
Summary of Clinical Laboratory Abnormalities
Weekly
AUC of KOS-1022 and its metabolites
Week 1 and Week 4: pretreatment, 30 and 55 minutes after start of infusion, 5, 15, 30 minutes and 1, 2, 4, 6, 24, 72 hours post-infusion; Weeks 2 and 3: pre-infusion
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALPatients whose last dose is \> 21 days prior to first dose of Trastuzumab on study. First infusion: 90 mins for 4 mg/kg loading dose of trastuzumab followed by 60 min infusion of alvespimycin. Subsequent infusions weekly 30 mins for 2 mg/kg trastuzumab followed by 60 min infusion of alvespimycin Patients whose last dose is \< 21 days prior to first dose of Trastuzumab on study. All infusions: 30 mins for 2 mg/kg trastuzumab followed by 60 min infusion of alvespimycin
Arm 2EXPERIMENTALPatients whose last dose is \> 21 days prior to first dose of Trastuzumab on study. First infusion: 90 mins for 4 mg/kg loading dose of trastuzumab followed by 60 min infusion of paclitaxel and 60 min of infusion of alvespimycin. Subsequent infusions weekly 30 mins for 2 mg/kg trastuzumab followed by 60 min infusion of paclitaxel and 60 min infusion of alvespimycin Patients whose last dose is \< 21 days prior to first dose of Trastuzumab on study. All infusions: 30 mins for 2 mg/kg trastuzumab followed by 60 min infusion of paclitaxel and 60 min infusion of alvespimycin. Subsequent infusions weekly 30 mins for 2 mg/kg trastuzumab followed by 60 min infusion of paclitaxel and 60 min infusion of alvespimycin

Interventions

NameTypeDescription
AlvespimycinDRUGSolution, IV, 60-100 mg/m2, weekly until disease progression or DLT
TrastuzumabDRUGSolution, IV, 2-4 mg/kg, weekly until disease progression or DLT
PaclitaxelDRUGSolution, IV, 60-90 mg/m2, weekly until disease progression or DLT
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * KPS performance status \>= 70% * Schedule A: all patients must have a histologically confirmed solid tumor malignancy. Schedule B: patients must have metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC"). Patients ar...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

Frequently asked questions about Alvespimycin

What is alvespimycin?

Alvespimycin is an investigational small molecule developed by Bristol-Myers Squibb Company (ticker BMY) for the treatment of solid tumors. It is an HSP90 inhibitor that has been studied in Phase 1 clinical development, including in patients with advanced solid tumor malignancies and HER2 positive metastatic breast cancer.

What does alvespimycin target?

Alvespimycin targets HSP90AA1 and HSP90AB1, two isoforms of the heat shock protein 90 chaperone. It acts as an inhibitor of these targets. By binding HSP90, the drug interferes with the chaperone function that supports the folding and stability of client proteins involved in tumor growth.

Who is developing alvespimycin?

Alvespimycin is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the Phase 1 clinical trial of the agent in advanced solid tumors and HER2 positive metastatic breast cancer.

What phase is alvespimycin in?

Alvespimycin is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single registered trial, NCT00803556, has been completed, and no active trials of alvespimycin are currently listed.

What clinical trials is alvespimycin in?

Alvespimycin has been evaluated in one completed Phase 1 trial, NCT00803556. That study tested intravenous alvespimycin (KOS-1022) combined with trastuzumab, with or without paclitaxel, in patients with advanced solid tumor malignancies or HER2 positive metastatic breast cancer who had previously failed trastuzumab therapy. It enrolled 29 patients in the United States.

Is alvespimycin the same as KOS-1022?

Yes, alvespimycin is also known as KOS-1022. The two names refer to the same investigational HSP90 inhibitor developed by Bristol-Myers Squibb. The Phase 1 trial NCT00803556 used the KOS-1022 designation in its title when studying the intravenous formulation in advanced solid tumors and HER2 positive metastatic breast cancer.