Clinical trial NCT00908024: Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors
Official title: A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Head and Neck Cancer
Neoplasm Metastasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective


Eligibility criteria: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* ECOG status 0 - 1
* Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
* Dose expansion: CRC (KRAS-WT) and head \& neck cancer subjects only

  1. must be able to provide 2 fresh tumor biopsy samples
  2. must have failed one prior cetuximab-containing treatment

Exclusion Criteria:

* Symptomatic brain metastasis
* Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
* Any condition requiring chronic use of steroids
* Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
* History of glucose intolerance
* History of cetuximab infusion reactions
* Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Primary outcomes:
measure: Maximum tolerated dose of BMS-754807 administered orally (daily schedule) in combination with cetuximab administered standard doses IV (weekly basis) will be determined by observation of dose limiting toxicities during the first 33 days of administration
timeFrame: During and at the end of the first 33 days after the first dose of BMS-754807 is given
Secondary outcomes:
measure: To assess anti-tumor activity as measured by objective responses
timeFrame: every 8 weeks
measure: To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen
timeFrame: Ongoing
measure: To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis
timeFrame: Ongoing
measure: Dose Expansion only: To identify biomarkers that are predictive of a response to BMS-754807/cetuximab combination therapy in advanced or metastatic CRC and SCCHN subjects with cetuximab resistance
timeFrame: tumor biopsies before treatment and on day 33 +/- 3 of treatment
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: