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Completed

NCT Number: NCT00207051

BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies

This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Hamilton, Ontario, 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 advanced or metastatic (tumor has spread) gastrointestinal malignancy
  • Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
  • Available tumor tissue sample from prior surgery
  • Measurable disease on scans
  • 4-6 weeks since prior therapy and recovered from the effects of prior therapy
  • Men and women, ages 18 and above
  • Women must not be pregnant or breastfeeding

Treatment and study plan

Brivanib + Cetuximab

Drug

Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks

Other names: Erbitux, BMS-564717

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 maximu 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 Combination With Full Dose Erbitux in Patients With Advanced Gastrointestinal Malignancies Who Have Failed Prior Therapy

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Jan 25, 2011

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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