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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00792558




Registration number
NCT00792558
Ethics application status
Date submitted
17/11/2008
Date registered
18/11/2008
Date last updated
1/09/2015

Titles & IDs
Public title
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
Scientific title
A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CA195-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-817378

Experimental: Single Arm -


Treatment: Drugs: BMS-817378
Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers
Timepoint [1] 0 0
Within the first 21 days after first dose of BMS-817378
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
All time points while subject is on study
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Day 22 +/-2
Secondary outcome [3] 0 0
Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833
Timepoint [3] 0 0
Days 1 and 15
Secondary outcome [4] 0 0
Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction
Timepoint [4] 0 0
All time points while subject is on study
Secondary outcome [5] 0 0
Describe preliminary evidence for anti-tumor activity of BMS-817378
Timepoint [5] 0 0
Every 6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2010
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Local Institution - Adelaide
Recruitment hospital [2] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects
with advanced cancers
Trial website
https://clinicaltrials.gov/ct2/show/NCT00792558
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00792558