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BMS-599626

Phase 1

HER2 or EGFR Expressing Advanced Solid Malignancies | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Mar 2, 2010

BMS-599626 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2004

BMS-599626 target and mechanism

ModalitySmall molecule

Also known as panHer

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment105

FDA Designations

No designations recorded

BMS-599626 clinical trials

BMS-599626 · 2 trials · 3 indications

Phase 1 2
NCT00207012MAD Refractory: Solid Tumor QD w/o BreakHER2 or EGFR Expressing Advanced Solid Malignancies
COMPLETED45 Analytics
NCT00095537BMS-599626 in Patients With Advanced Solid MalignanciesCancer
COMPLETED60 Analytics
PHASE1COMPLETED
MAD Refractory: Solid Tumor QD w/o Break
HER2 or EGFR Expressing Advanced Solid MalignanciesUnlock trial analytics
PHASE1COMPLETED
BMS-599626 in Patients With Advanced Solid Malignancies
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the maximum tolerated, biologically active doses and recommended phase 2 dose(s) of BMS-599-626 when administered as a daily uninterrupted oral dose
Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy

Secondary Endpoints

Efficacy (Best Clinical Response)
Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 MTD StudyEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-599626DRUG -
panHerDRUGTablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.
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Eligibility Criteria

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

Inclusion Criteria: * Signed written informed consent * Available for periodic follow-up * Life expectancy of at least 3 months * ECOG performance status score 0-1 * Histologic or cytologic diagnosis of a primary malignancy of breast, ovarian, bladder, gastric, non small cell lung or colon origin *...

Countries:FranceSpainUnited States
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Frequently asked questions about BMS-599626

What is BMS-599626 used for?

BMS-599626 is an investigational small molecule being studied in adults with HER2 or EGFR expressing advanced solid malignancies. It was evaluated in a Phase 1 dose-escalation study in patients with these biomarker-selected tumors. It is not an approved therapy; it remains in clinical development for oncology indications.

What does BMS-599626 target?

BMS-599626 targets HER2 and EGFR, two receptor tyrosine kinases that drive growth signaling in certain solid tumors. Because it acts on both receptors, the clinical program selected patients whose tumors express HER2 or EGFR. This dual targeting is the basis for its evaluation in advanced solid malignancies.

Who is developing BMS-599626?

BMS-599626 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the compound in patients with HER2 or EGFR expressing advanced solid malignancies.

What phase is BMS-599626 in?

BMS-599626 is in Phase 1 development. Its only recorded clinical study was a Phase 1 dose-escalation trial that has completed. The drug is investigational and has not been approved for any indication.

What clinical trials is BMS-599626 in?

BMS-599626 was studied in one Phase 1 trial, NCT00207012, titled MAD Refractory: Solid Tumor QD w/o Break. That study enrolled 45 adults with HER2 or EGFR expressing advanced solid malignancies in France and Spain. It was an uncontrolled, non-randomized, open-label trial and is now completed, with no active trials ongoing.

Is BMS-599626 biomarker selected?

Yes. BMS-599626 was studied in a biomarker-selected population, enrolling only patients whose advanced solid malignancies expressed HER2 or EGFR. The Phase 1 trial NCT00207012 used this expression criterion for entry and enrolled 45 adults across sites in France and Spain.