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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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/show/NCT00792558