Clinical trial NCT00792558: Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
Official title: A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 0
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 purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
* ECOG status 0-1

Exclusion Criteria:

* WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
* Symptomatic brain metastasis
* Uncontrolled or significant cardiovascular disease
* History of thromboembolic events or bleeding diathesis in past 6 months
* Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
* Serious non-healing wounds, ulcers or bone fractures in past 3 months
* Hemorrhage or bleeding event \>= CTCAE grade 3 in past 4 weeks
* Proteinuria \>= 2+ on dipstick or \>= 1gm/24 hours
* Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product
* Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers

Primary outcomes:
measure: To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers
timeFrame: Within the first 21 days after first dose of BMS-817378
Secondary outcomes:
measure: Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
timeFrame: All time points while subject is on study
measure: Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)
timeFrame: Day 22 +/-2
measure: Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833
timeFrame: Days 1 and 15
measure: Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction
timeFrame: All time points while subject is on study
measure: Describe preliminary evidence for anti-tumor activity of BMS-817378
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Singapore
country: Singapore
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: