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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/NCT00605618




Registration number
NCT00605618
Ethics application status
Date submitted
18/01/2008
Date registered
31/01/2008
Date last updated
25/01/2011

Titles & IDs
Public title
Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Scientific title
A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CA192-002
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-777607

Experimental: Single Arm -


Treatment: Drugs: BMS-777607
Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 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
Safety and efficacy assessment including vitals signs, physical assessments, and blood tests
Timepoint [1] 0 0
will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months
Primary outcome [2] 0 0
Tumor assessments
Timepoint [2] 0 0
will be conducted every 6 weeks. All assessments will continue for at least 24 months
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669
Timepoint [1] 0 0
will be assessed once weekly for the first 3 weeks
Secondary outcome [2] 0 0
The effects of BMS-777607 on blood pressure (BP), heart rate (HR)
Timepoint [2] 0 0
will be assessed once weekly for the first 3 weeks then every 3 weeks
Secondary outcome [3] 0 0
Effects on electrocardiogram (ECG), PR interval
Timepoint [3] 0 0
will be assessed at base line, at week 3 and at end of treatment
Secondary outcome [4] 0 0
Effects on left ventricular function
Timepoint [4] 0 0
will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months

Eligibility
Key inclusion criteria
Part A:

- Subjects with advanced or metastatic solid tumors who have either progressed on
standard therapy or for whom standard therapy is not known

Part B:

- Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC
who have either progressed on standard therapy, or for whom standard therapy is not
known. Eighteen (18) subjects each with gastroesophageal cancer, HRPrC, and HNSCC will
be treated. Subjects with PRCC (up to 18) will be enrolled as feasible

- Tumor paraffin tissue block or 6-10 unstained slides from the tumor tissue block must
be provided

- Subjects with HRPrC must have either measurable disease or rising PSA levels (=3
consecutive rising levels with at least 1 week interval and with PSA level =5 mg/ml).
All other subjects must have measurable disease as assessed by CT or MRI
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Know brain metastases

- Uncontrolled or significant cardiovascular disease

- Retinal atrophy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Kogarah
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah

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

Ethics approval
Ethics application status

Summary
Brief summary
Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in
subjects with advanced or metastatic solid tumors

Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in
subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate
cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma
Trial website
https://clinicaltrials.gov/ct2/show/NCT00605618
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/NCT00605618