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Completed

NCT Number: NCT00207103

MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.

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Key information

Conditions

Tumors Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
  • No tumor spread to the brain
  • Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
  • Available tumor tissue sample from prior surgery
  • 4-6 weeks since prior therapy and recovered from prior therapy
  • Men and women, ages 18 and above
  • Women must not be pregnant or breastfeeding
  • Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
  • Measurable disease on scans (at least one)

Treatment and study plan

Brivanib

Drug

Tablets, Oral, 180 mg, once daily, until disease progression

Other names: BMS-582664

Brivanab

Drug

Tablets, Oral, 1000 mg, once daily, until disease progression

Other names: BMS-582664

Primary outcomes

  1. Safety assessment

    Time frame: throughout the study

  2. dose-limiting toxicity (DLT)

    Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified

  3. determination of maximum tolerated dose (MTD)

    Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified

Secondary outcomes

  1. Efficacy based on duration of response and time to progression based on assessment

    Time frame: measured every 8 weeks throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Nov 4, 2008

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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