NCT00207051

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Timeline
Completed

Started Jan 2006

Geographic Reach
3 countries

8 active sites

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

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 25, 2011

Status Verified

March 1, 2009

Enrollment Period

2.9 years

First QC Date

September 12, 2005

Last Update Submit

January 24, 2011

Conditions

Colorectal Cancer

Keywords

Advanced Gastrointestinal Malignancies

Outcome Measures

Primary Outcomes (3)

  • Safety assessment

    throughout the study

  • dose limiting toxicity (DLT)

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

  • determination of maximum tolerated dose (MTD)

    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

    Measured every 8 weeks throughout the study

Study Arms (1)

1

EXPERIMENTAL
Drug: Brivanib + Cetuximab

Interventions

Brivanib + CetuximabDRUG

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

Also known as: Erbitux, BMS-564717
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Georgetn Univ Lombardi Can Ctr

Washington D.C., District of Columbia, 20007, United States

Location

University Of Miami Miller School Of Medicine

Miami, Florida, 33010, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Local Institution

Hamilton, Ontario, L8V 2C5, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (1)

  • Jonker DJ, Rosen LS, Sawyer MB, de Braud F, Wilding G, Sweeney CJ, Jayson GC, McArthur GA, Rustin G, Goss G, Kantor J, Velasquez L, Syed S, Mokliatchouk O, Feltquate DM, Kollia G, Nuyten DSA, Galbraith S. A phase I study to determine the safety, pharmacokinetics and pharmacodynamics of a dual VEGFR and FGFR inhibitor, brivanib, in patients with advanced or metastatic solid tumors. Ann Oncol. 2011 Jun;22(6):1413-1419. doi: 10.1093/annonc/mdq599. Epub 2010 Dec 3.

    PMID: 21131369DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

brivanibCetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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

September 12, 2005

First Posted

September 21, 2005

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 25, 2011

Record last verified: 2009-03

Locations

US(5)CA(2)NL(1)