Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516451

Enrollment

Registered

2007-08-15

Start date

2007-11-30

Completion date

2008-07-31

Last updated

2008-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGBMS-690514

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514	administered orally every day 28 days

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026