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

Bristol-Myers Squibb5 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Carcinoma

Interventions

BMS-833923DRUG

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

CarboplatinDRUG

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

EtoposideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (6)

Karmanos Cancer Institute

Detroit, Michigan, United States

Local Institution

East Bentleigh, Victoria, Australia

Local Institution

Edmonton, Alberta, Canada

Local Institution

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 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]

Time frame: 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

Time frame: At baseline and after 1 week

Data from ClinicalTrials.gov

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