Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan

Phase 1 Multiple Ascending Dose Study of BMS-907351 (XL184) Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018745

Enrollment

Registered

2009-11-25

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Brief summary

The purpose of this clinical study is to establish the maximum tolerated dose (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.

Interventions

DRUGBMS-907351 (XL184)

Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity	Day 1, 5, 15, 19, 29 and every 4 weeks thereafter

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026