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Completed

NCT Number: NCT00898716

Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with 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 0-1

Exclusion criteria

  • Any disorder with dysregulation of glucose homeostasis
  • Dumping syndrome
  • History of glucose intolerance

Treatment and study plan

BMS-754807

Drug

Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response

Primary outcomes

  1. To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days

    Time frame: Within the first 28 days

Secondary outcomes

  1. To assess the safety and tolerability

    Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  2. To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule

    Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  3. To assess the metabolic effect on blood glucose

    Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  4. To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule

    Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  5. To assess any preliminary evidence of anti-tumor activity

    Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  6. To explore potential biomarkers of biological response

    Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 12, 2009
Registry last updated
Nov 30, 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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