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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00793897




Registration number
NCT00793897
Ethics application status
Date submitted
17/11/2008
Date registered
19/11/2008
Date last updated
13/07/2012

Titles & IDs
Public title
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors
Scientific title
A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CA191-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Sequential allocation of patients in two dosing schedules -


Treatment: Drugs: BMS-754807
Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request

Treatment: Drugs: Paclitaxel
Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request

Treatment: Drugs: Carboplatin
Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, 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: starting with dosing on Day 1 until after 30 day follow-up following the last dose
Secondary outcome [1] 0 0
Pharmacodynamics: Biochemical parameters of drug action in serum
Timepoint [1] 0 0
assessed every 6 weeks of the study
Secondary outcome [2] 0 0
Metabolic measures: Effects of the drug on parameters of glucose homeostasis
Timepoint [2] 0 0
assessed every 6 weeks of the study
Secondary outcome [3] 0 0
Efficacy Measures: PET scans and tumor assessments by CT/MRI
Timepoint [3] 0 0
a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks
Secondary outcome [4] 0 0
Pharmacokinetic Measures: Blood samples will be collected during pre-specified times
Timepoint [4] 0 0
Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)

Eligibility
Key inclusion criteria
* Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy
* 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
* Evidence of > Grade 1 peripheral neuropathy

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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - East Melbourne
Recruitment hospital [2] 0 0
Local Institution - Parville
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Parville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul

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/NCT00793897