Clinical trial NCT00207051: BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: Advanced Gastrointestinal Malignancies
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety assessment
timeFrame: throughout the study
measure: dose limiting toxicity (DLT)
timeFrame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
measure: determination of maximum tolerated dose (MTD)
timeFrame: 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:
measure: Efficacy based on duration of response and time to progression based on assessment
timeFrame: Measured every 8 weeks throughout the study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center
state: California
city: Washington
country: United States
facility: Georgetn Univ Lombardi Can Ctr
state: District of Columbia
city: Miami
country: United States
facility: University Of Miami Miller School Of Medicine
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Amsterdam
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.