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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00927875




Registration number
NCT00927875
Ethics application status
Date submitted
9/06/2009
Date registered
24/06/2009
Date last updated
31/05/2013

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
Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell

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

Experimental: All Subjects -

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

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 - NCI - National Cancer Institute
CTCAE - Common Terminology Criteria for Adverse Events
MTD - Maximum tolerated dose
DLT - Dose limiting toxicity
Timepoint [1] 0 0
28 days
Primary outcome [2] 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 - NCI - National Cancer Institute
CTCAE - Common Terminology Criteria for Adverse Events
MTD - Maximum tolerated dose
DLT - Dose limiting toxicity
Timepoint [2] 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
Secondary outcome [6] 0 0
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax)
Timepoint [6] 0 0
Day 1 and 15 of first three 21-day cycles
Secondary outcome [7] 0 0
Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax)
Timepoint [7] 0 0
Day 1 and 15 of first three 21-day cycles
Secondary outcome [8] 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 [8] 0 0
Day 1 and 15 of first three 21-day cycles
Secondary outcome [9] 0 0
Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]
Timepoint [9] 0 0
Every 6 weeks until disease progression
Secondary outcome [10] 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 [10] 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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Exelixis
Address [2] 0 0
Country [2] 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/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
Other publications