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Alvespimycin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Solid Tumor")

Frequently asked questions about Alvespimycin

What is Alvespimycin used for?

Alvespimycin is an investigational small molecule being studied for the treatment of solid tumors, including HER2 positive metastatic breast cancer. It was evaluated in a Phase 1 clinical trial in patients with advanced solid tumor malignancies or HER2 positive metastatic breast cancer who had previously failed trastuzumab therapy.

Who makes Alvespimycin?

Alvespimycin is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company sponsored a Phase 1 clinical trial of the drug in combination with trastuzumab, with or without paclitaxel, in patients with advanced solid tumors.

What phase is Alvespimycin in?

Alvespimycin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single Phase 1 trial of Alvespimycin has been completed, and the drug is no longer in active clinical trials.

What clinical trials is Alvespimycin in?

Alvespimycin was studied in one completed Phase 1 clinical trial, identified as NCT00803556. This trial evaluated the combination of intravenous Alvespimycin, trastuzumab, with or without paclitaxel, in patients with advanced solid tumor malignancies or HER2 positive metastatic breast cancer who had previously failed trastuzumab therapy.

Is Alvespimycin the same as KOS-1022?

Yes, Alvespimycin is also known as KOS-1022. The clinical trial NCT00803556 refers to the drug as Alvespimycin (KOS-1022), indicating that these names are used interchangeably for the same investigational compound.