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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Carcinoma

Intervention: BMS-833923 (Drug); Carboplatin (Drug); Etoposide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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).

Clinical Details

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

Primary outcome: Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide

Secondary outcome:

Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Maximum observed plasma concentration (Cmax)

Pharmacokinetic parameters of BMS-833923 alone and in combination with carboplatin and etoposide: Time of maximum observed plasma concentration (Tmax)

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)

Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]

Pharmacodynamic effect (change from baseline) of BMS-833923 on Hedgehog pathway activation as measured by Glioma-associated oncogene -1 (GLI-1) expression

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Local Institution, Villejuif Cedex 94800, France

Local Institution, Dublin, Ireland

Local Institution, Edmonton, Alberta T6G 1Z2, Canada

Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Local Institution, Ottawa, Ontario K1H 8L6, Canada

Local Institution, East Bentleigh, Victoria 3165, Australia

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2010
Last updated: May 31, 2013

Page last updated: August 23, 2015

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