A Study of BMS-833923 With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927875
• Other study ID #: CA194-005
• Secondary ID: 2010-018745-56
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2009
• Last updated: May 31, 2013
• Start date: February 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ireland: Irish Medicines BoardAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• BMS-833923
Capsule, Oral, starting dose 30 mg, once daily, continuous
• Carboplatin
Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles
• 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

Locations

Country	Name	City	State
Australia	Local Institution	East Bentleigh	Victoria
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Ottawa	Ontario
France	Local Institution	Villejuif Cedex
Ireland	Local Institution	Dublin
United States	Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Exelixis

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days	Yes
Secondary	Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax)		Day 1 and 15 of first three 21-day cycles	No
Secondary	Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax)		Day 1 and 15 of first three 21-day cycles	No
Secondary	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)		Day 1 and 15 of first three 21-day cycles	No
Secondary	Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]		Every 6 weeks until disease progression	No
Secondary	Pharmacodynamic effect (change from baseline) of BMS-833923 on Hedgehog pathway activation as measured by Glioma-associated oncogene -1 (GLI-1) expression		At baseline and after 1 week	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form