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


Phase 1
20 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Within the first 28 days

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA205-001

NCT ID:

NCT01018745

Start Date:

January 2010

Completion Date:

July 2010

Related Keywords:

  • Neoplasms
  • Neoplasms

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