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Completed

NCT Number: NCT01018745

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

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.

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-907351 (XL184)

Drug

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

Primary outcomes

  1. 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

    Time frame: Within the first 28 days

Secondary outcomes

  1. 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

    Time frame: Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter

  2. To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors

    Time frame: Day 1, 5, 15, 19 and 29

  3. To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)

    Time frame: Every 8 weeks

  4. To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity

    Time frame: Day 1, 5, 15, 19, 29 and every 4 weeks thereafter

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2009
Registry last updated
Jan 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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