A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390936

Enrollment

Registered

2006-10-23

Start date

2007-10-31

Completion date

2010-03-31

Last updated

2011-01-25

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

Conditions

Solid Tumors

Brief summary

The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.

Interventions

DRUGBrivanib

Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must have measurable disease * Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator * ECOG PS: 0-1

Exclusion criteria

* Subjects with centrally located squamous cell carcinoma of the lung

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicity	at the end of the first cycle of the study
Maximum Tolerated Dose	at the end of the first cycle of the study

Secondary

Measure	Time frame
To assess any preliminary evidence of anti-tumor activity observed with BMS-582664	at the end of the study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026