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panHer

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

panHer · 1 trial · 2 indications

Phase 1 1
NCT00095537BMS-599626 in Patients With Advanced Solid MalignanciesCancer
COMPLETED60 Analytics
PHASE1COMPLETED
BMS-599626 in Patients With Advanced Solid Malignancies
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 MTD StudyEXPERIMENTAL -

Interventions

NameTypeDescription
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 Sites3

Inclusion Criteria: * Diagnosis of metastatic cancer that has progressed on currently available therapies; * At least 3 month life expectancy; * Primary cancer must be solid (non-hematologic); * Adequate bone marrow, liver \& kidney function; * Negative pregnancy test. Exclusion Criteria: * Serio...

Countries:United States
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Frequently asked questions about panHer

What is panHer used for?

panHer is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes panHer?

panHer is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's potential in treating cancer.

What phase is panHer in?

panHer is currently in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 60 patients with advanced solid malignancies. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is panHer in?

panHer has been studied in one clinical trial with the identifier NCT00095537, titled "BMS-599626 in Patients With Advanced Solid Malignancies." This Phase 1 trial was completed in the United States and enrolled 60 adult patients with cancer or metastases.

Is panHer the same as BMS-599626?

Yes, panHer is also known as BMS-599626. The completed Phase 1 clinical trial NCT00095537 used the name BMS-599626 to refer to the drug, confirming that both names identify the same investigational compound.