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BMS-754807

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 14, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

BMS-754807 · 5 trials · 7 indications

Phase 1 5
NCT01525823Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With MetforminHealthy Volunteers
COMPLETED26 Analytics
NCT00898716Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in JapanNeoplasms
COMPLETED15 Analytics
NCT00788333Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast CancerBreast Cancer
COMPLETED40 Analytics
NCT00793897Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors
COMPLETED21 Analytics
NCT00569036Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid TumorsNeoplasms
COMPLETED63 Analytics
PHASE1COMPLETED
Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
NeoplasmsUnlock trial analytics
PHASE1COMPLETED
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
Breast CancerUnlock trial analytics
PHASE1COMPLETED
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
On Day 3 and Day 17
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days
Within the first 28 days
The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis
Every 30 days until MTD is reached
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Continuous assessment throughout the duration of the trial

Secondary Endpoints

Safety endpoints: AEs and marked clinical laboratory abnormalities
Day -21 to Day 47
Maximum observed plasma concentration (Cmax) of BMS-754807 and M5
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
BMS-754807 + MetforminEXPERIMENTAL -
BMS-754807EXPERIMENTAL -
AEXPERIMENTALCombination
Sequential allocation of patients in two dosing schedulesEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-754807 (IGR-IR/IR Inhibitor)DRUGTablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
MetforminDRUGTablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
BMS-754807DRUGTablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response
trastuzumab (Herceptin®)DRUGIV solution, IV, 4mg/kg Day 1 loading dose, 2mg/kg once weekly, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
PaclitaxelDRUGVials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
CarboplatinDRUGVials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory * Women who are not of childbearing potential Exclusion Criteria: * Eviden...

Countries:AustraliaJapanBelgiumCanadaHungaryUnited KingdomSouth Korea
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about BMS-754807

What is BMS-754807 used for?

BMS-754807 is an investigational small molecule being studied in oncology. It has been evaluated in clinical trials for breast cancer, advanced solid tumors, metastatic solid tumors, and neoplasms, as well as in healthy volunteers for glucose-related assessments. It is not approved and remains in clinical development.

Who makes BMS-754807?

BMS-754807 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has sponsored multiple Phase 1 clinical trials of this investigational oncology drug.

What phase is BMS-754807 in?

BMS-754807 is in Phase 1 clinical development. All four completed trials were Phase 1 studies. It is an investigational drug and has not been approved by regulatory authorities. No active trials are currently listed for this asset.

What clinical trials is BMS-754807 in?

BMS-754807 has completed four Phase 1 trials: NCT00788333 combining it with Herceptin in HER2-positive breast cancer, NCT00793897 combining it with paclitaxel and carboplatin in advanced solid tumors, NCT00898716 a multiple ascending dose study in Japanese patients with solid tumors, and NCT01525823 assessing blood glucose changes in healthy volunteers.

Is BMS-754807 the same as Herceptin?

No, BMS-754807 is not the same as Herceptin. BMS-754807 is an investigational small molecule developed by Bristol-Myers Squibb, while Herceptin is a separate drug. They were studied in combination in a Phase 1 trial for HER2-positive breast cancer, but they are distinct agents.