Clinical trial NCT00927875: A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Exelixis
First posted: 2009-06-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

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

Primary outcomes:
measure: Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax)
timeFrame: Day 1 and 15 of first three 21-day cycles
measure: Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax)
timeFrame: Day 1 and 15 of first three 21-day cycles
measure: 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)
timeFrame: Day 1 and 15 of first three 21-day cycles
measure: Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]
timeFrame: Every 6 weeks until disease progression
measure: Pharmacodynamic effect (change from baseline) of BMS-833923 on Hedgehog pathway activation as measured by Glioma-associated oncogene -1 (GLI-1) expression
timeFrame: At baseline and after 1 week
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: East Bentleigh
country: Australia
facility: Local Institution
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Villejuif Cedex
country: France
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: