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BMS-777607

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

BMS-777607 · 1 trial · 1 indication

Phase 1 1
NCT00605618Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors
COMPLETED8 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and efficacy assessment including vitals signs, physical assessments, and blood tests
will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months
Tumor assessments
will be conducted every 6 weeks. All assessments will continue for at least 24 months

Secondary Endpoints

Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669
will be assessed once weekly for the first 3 weeks
The effects of BMS-777607 on blood pressure (BP), heart rate (HR)
will be assessed once weekly for the first 3 weeks then every 3 weeks
Effects on electrocardiogram (ECG), PR interval
will be assessed at base line, at week 3 and at end of treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-777607DRUGSuspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation
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Eligibility Criteria

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

Inclusion Criteria: Part A: * Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known Part B: * Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on sta...

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

Frequently asked questions about BMS-777607

What is BMS-777607 used for?

BMS-777607 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and has been evaluated in a completed clinical trial involving patients with advanced or metastatic solid tumors.

Who makes BMS-777607?

BMS-777607 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is BMS-777607 in?

BMS-777607 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug has been completed, but it remains in early-stage clinical testing for advanced solid tumors.

What clinical trials is BMS-777607 in?

BMS-777607 has been studied in one completed clinical trial, registered as NCT00605618. This was a multiple ascending dose study conducted in Australia with 8 participants who had advanced or metastatic solid tumors. The trial was an uncontrolled, non-randomized, open-label Phase 1 study.

Is BMS-777607 the same as any other drug?

BMS-777607 is the primary name for this investigational drug. No alternative names have been reported for this compound in clinical development. It is being studied under this identifier in the clinical trial registry.