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panHer

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Mar 2, 2010

panHer development status

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

panHer target and mechanism

ModalitySmall molecule

Also known as BMS-599626

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment105

FDA Designations

No designations recorded

panHer clinical trials

panHer · 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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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about panHer

What is panHer used for?

panHer is an investigational small molecule developed for the treatment of cancer. It was studied in patients with advanced solid malignancies, including metastatic disease, in a Phase 1 trial. It is not an approved therapy and remains in clinical development.

Who is developing panHer?

panHer 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 advanced solid tumors.

What phase is panHer in?

panHer is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 60 patients with advanced solid malignancies and metastatic disease.

What clinical trials is panHer in?

panHer has been evaluated in one completed Phase 1 trial, NCT00095537, titled BMS-599626 in Patients With Advanced Solid Malignancies. The study enrolled 60 adults aged 18 years and older in the United States and included a randomized design.

Is panHer FDA approved?

No. panHer is an investigational agent and has not been approved by the FDA. It has completed only a single Phase 1 trial in patients with advanced solid malignancies, so it remains in early clinical development for cancer.