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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927875

Enrollment

Registered

2009-06-25

Start date

2010-02-28

Completion date

2012-09-30

Last updated

2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Carcinoma

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).

Interventions

DRUGBMS-833923

Capsule, Oral, starting dose 30 mg, once daily, continuous

DRUGCarboplatin

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

DRUGEtoposide

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Use NCI CTCAE to establish the MTD, DLT(s) and safety profile of BMS-833923 administered alone and in combination with carboplatin and etoposide	28 days	* NCI - National Cancer Institute * CTCAE - Common Terminology Criteria for Adverse Events * MTD - Maximum tolerated dose * DLT - Dose limiting toxicity

Secondary

Measure	Time frame
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
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
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
Tumor assessments by computed tomography (CT) [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]	Every 6 weeks until disease progression
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

Countries

Australia, Canada, France, Ireland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026