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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/NCT00927875




Registration number
NCT00927875
Ethics application status
Date submitted
9/06/2009
Date registered
25/06/2009
Date last updated
3/06/2013

Titles & IDs
Public title
A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer
Scientific title
A Phase 1b Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-833923 (XL139) in Combination With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer
Secondary ID [1] 0 0
2010-018745-56
Secondary ID [2] 0 0
CA194-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-833923
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide

Experimental: All Subjects -


Treatment: Drugs: BMS-833923
Capsule, Oral, starting dose 30 mg, once daily, continuous

Treatment: Drugs: Carboplatin
Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles

Treatment: Drugs: Etoposide
Vial, Intravenous (IV), 100 mg/m²/dose, days 1, 2, & 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1 and 15 of first three 21-day cycles
Secondary outcome [2] 0 0
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax)
Timepoint [2] 0 0
Day 1 and 15 of first three 21-day cycles
Secondary outcome [3] 0 0
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Area under the concentration-time curve in one dosing interval AUC(TAU)
Timepoint [3] 0 0
Day 1 and 15 of first three 21-day cycles
Secondary outcome [4] 0 0
Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]
Timepoint [4] 0 0
Every 6 weeks until disease progression
Secondary outcome [5] 0 0
Pharmacodynamic effect (change from baseline) of BMS-833923 on Hedgehog pathway activation as measured by Glioma-associated oncogene -1 (GLI-1) expression
Timepoint [5] 0 0
At baseline and after 1 week

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed small cell lung cancer, without prior
chemotherapy treatment

- Men and Women at least 18 years old

- Eastern Cooperative Oncology Group (ECOG) status 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant cardiovascular disease

- Prior treatment of small cell lung cancer is not permitted, except for palliative
radiation to a limited field excluding the chest (e.g. for painful metastasis).

- Symptomatic brain metastases

- Women pregnant or breastfeeding

- Women of childbearing potential (WOCBP) unwilling/unable to use acceptable method to
avoid pregnancy

- Uncontrolled medical disorder or active infection

- Concurrent therapy with any other investigational product

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - East Bentleigh
Recruitment postcode(s) [1] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
France
State/province [4] 0 0
Villejuif Cedex
Country [5] 0 0
Ireland
State/province [5] 0 0
Dublin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Exelixis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923
administered in combination with carboplatin and etoposide followed by BMS-833923 alone in
subjects with extensive-stage Small Cell Lung Cancer (SCLC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00927875
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/NCT00927875