Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00569036




Registration number
NCT00569036
Ethics application status
Date submitted
4/12/2007
Date registered
6/12/2007
Date last updated
14/08/2013

Titles & IDs
Public title
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
Scientific title
A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CA191-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-754807

Experimental: BMS-754807 - Single arm, multiple-ascending dose escalation study


Treatment: Drugs: BMS-754807
Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Timepoint [1] 0 0
Continuous assessment throughout the duration of the trial
Secondary outcome [1] 0 0
Pharmacokinetics
Timepoint [1] 0 0
assessed during the first 4 weeks of the study
Secondary outcome [2] 0 0
Pharmacodynamics
Timepoint [2] 0 0
assessed during the first 4 weeks of the study
Secondary outcome [3] 0 0
Metabolic measures
Timepoint [3] 0 0
assessed during the first 4 weeks of the study
Secondary outcome [4] 0 0
ECG
Timepoint [4] 0 0
assessed during the first 4 weeks of the study
Secondary outcome [5] 0 0
Efficacy Measures
Timepoint [5] 0 0
assessed every 8 weeks

Eligibility
Key inclusion criteria
- Subjects with advanced or metastatic solid tumors for whom the standard of care is
ineffective or inappropriate

- ECOG performance status 0-1

- at least 4 weeks between surgery or last dose prior anti-cancer therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- symptomatic brain metastases

- any disorder or dysregulation of glucose homeostasis {e.g. diabetes)

- uncontrolled or significant cardiovascular disease

- inadequate bone marrow, liver or kidney function

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
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Local Institution - East Melbourne
Recruitment hospital [2] 0 0
Local Institution - Footscray
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment hospital [5] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1 dose escalation study to determine the safety, tolerability,
pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in
patients with advanced or metastatic solid tumors. In addition, the study is expected to
identify the recommended dose or dose range of BMS-754807 for Phase 2 studies
Trial website
https://clinicaltrials.gov/ct2/show/NCT00569036
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/NCT00569036