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BMS-907351

Phase 1

Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 7, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

BMS-907351 · 1 trial · 1 indication

Phase 1 1
NCT01018745Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in JapanNeoplasms
COMPLETED3 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Within the first 28 days

Secondary Endpoints

To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter
To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors
Day 1, 5, 15, 19 and 29
To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)
Every 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-907351 (XL184)EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-907351 (XL184)DRUGCapsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent
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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 0-2 Exclusion Criteria: * Subject has uncontrolled intercurrent illness

Countries:Japan
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Frequently asked questions about BMS-907351

What is BMS-907351 used for?

BMS-907351 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for oncology indications.

Who makes BMS-907351?

BMS-907351 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY.

What phase is BMS-907351 in?

BMS-907351 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is BMS-907351 in?

BMS-907351 has one completed clinical trial, NCT01018745, titled 'Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan.' This was a Phase 1, uncontrolled study with 3 participants.

Is BMS-907351 the same as XL184?

Yes, BMS-907351 is also known as XL184. The clinical trial NCT01018745 refers to the drug as BMS-907351 (XL184), indicating that these names refer to the same investigational compound.