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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/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
A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and
preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs,
paclitaxel and carboplatin, 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
in combination with paclitaxel and carboplatin for Phase 2 studies
Trial website
https://clinicaltrials.gov/ct2/show/NCT00793897
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