NCT00898716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 30, 2011

Status Verified

July 1, 2010

Enrollment Period

1.8 years

First QC Date

May 11, 2009

Last Update Submit

November 29, 2011

Conditions

Neoplasms

Outcome Measures

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

    Within the first 28 days

Secondary Outcomes (6)

  • To assess the safety and tolerability

    Day 1, 8, 15, 22, 29, thereafter every 2 weeks

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

    Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  • To assess the metabolic effect on blood glucose

    Day 1, 8, 15, 22, 29, thereafter every 2 weeks

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

    Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  • To assess any preliminary evidence of anti-tumor activity

    Day 1, 8, 15, 22, 29, thereafter every 2 weeks

  • +1 more secondary outcomes

Study Arms (1)

BMS-754807

EXPERIMENTAL
Drug: BMS-754807

Interventions

BMS-754807DRUG

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

BMS-754807

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BMS 754807

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 30, 2011

Record last verified: 2010-07

Locations

JP(1)