Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00569036