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BMS-754807

Phase 2

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

BMS-754807 development status

Highest phase Phase 2 (NCT01225172)
Phase scored for BMYPhase 1
Registered trials 6 across 1 sponsor since Dec 2007

BMS-754807 target and mechanism

Molecular targetINSR, IGF1R
Target classInhibitor
ModalitySmall molecule

Also known as IGF-IR

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials4
Total Enrollment139

FDA Designations

No designations recorded

BMS-754807 clinical trials

BMS-754807 · 4 trials · 6 indications

Phase 1 4
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
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

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

To assess the safety and tolerability
Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule
Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the metabolic effect on blood glucose
Day 1, 8, 15, 22, 29, thereafter every 2 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
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 Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group performance 0-1 Exclusion Criteria: * Any disorder with dysregulation of glucose homeostasis * Dumpin...

Countries:JapanAustraliaBelgiumCanadaHungaryUnited KingdomSouth Korea
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Competitive Landscape -Other Solid Tumors 10 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 for the treatment of advanced or metastatic solid tumors, neoplasms, and HER2-positive breast cancer. It has been evaluated in Phase 1 clinical trials, both as a single agent and in combination with other therapies such as paclitaxel, carboplatin, and Herceptin.

What does BMS-754807 target?

BMS-754807 targets insulin receptor (INSR) and insulin-like growth factor 1 receptor (IGF1R). It is classified as an inhibitor of these targets. By inhibiting INSR and IGF1R, BMS-754807 interferes with signaling pathways that can promote tumor cell growth and survival.

Who is developing BMS-754807?

BMS-754807 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. Bristol-Myers Squibb is the sponsor of the clinical trials evaluating this agent.

What phase is BMS-754807 in?

BMS-754807 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. All completed trials were Phase 1 studies designed to assess safety, tolerability, and dosing in patients with solid tumors or breast cancer.

What clinical trials is BMS-754807 in?

BMS-754807 has been evaluated in completed Phase 1 trials including NCT00898716 in Japanese patients with solid tumors, NCT00793897 in combination with paclitaxel and carboplatin, NCT00788333 with Herceptin in HER2-positive breast cancer, and NCT00569036 in advanced or metastatic solid tumors. All trials are completed.