Clinical trial NCT00329004: A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
Official title: A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Tumor
Keywords: Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 and older
* Diagnosis of any solid tumor
* ECOG performance status score 0-1
* Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
* Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

Exclusion Criteria:

* Treatment with other TKIs within the past 4 weeks
* Patients with brain metastasis
* Patients with centrally located squamous cell carcinoma of the lung
* Major gastrointestinal surgery which may affect absorption of the drug
* Any surgery within last 4 weeks
* History of thromboembolism
* Severe unmanageable diarrhea
* Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
* Part B/Cohort I erlotinib-naive subjects
* Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)

Primary outcomes:
measure: Safety
timeFrame: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
measure: Highest dose tolerated
timeFrame: continuous medical review of adverse event reports
Secondary outcomes:
measure: Effective dose or doses of BMS-690514
timeFrame: tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Med Center
state: Indiana
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toulouse
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Soria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13.