NCT00516451

Brief Summary

The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_1 cancer

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

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 13, 2008

Status Verified

July 1, 2008

Enrollment Period

8 months

First QC Date

August 14, 2007

Last Update Submit

October 10, 2008

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514

    administered orally every day 28 days

Secondary Outcomes (3)

  • Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days.

    throughout the study

  • Safety evaluations and laboratory assessments will be performed

    throughout the study

  • Preliminary markers of efficacy will also be assessed

    throughout the study

Study Arms (1)

1

EXPERIMENTAL
Drug: BMS-690514

Interventions

BMS-690514DRUG

Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more

1

Eligibility Criteria

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

You may qualify if:

  • Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Related Publications (1)

  • Nokihara H, Yamamoto N, Yamada Y, Yamada K, Hirata T, Goto Y, Tanioka M, Ikeda Y, Tamura T. A phase I study of BMS-690514 in Japanese patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2012 Oct;70(4):559-65. doi: 10.1007/s00280-012-1932-9. Epub 2012 Aug 10.

    PMID: 22878519DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-690514

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

November 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 13, 2008

Record last verified: 2008-07

Locations

JP(1)