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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

Primary Purpose

Small Cell Lung Carcinoma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-833923

Carboplatin

Etoposide

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Karmanos Cancer Institute
Local Institution
Local Institution
Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Subjects

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00927875

First Posted

June 9, 2009

Last Updated

May 31, 2013

Sponsor

Bristol-Myers Squibb

Collaborators

Exelixis

1. Study Identification

Unique Protocol Identification Number

NCT00927875

Brief Title

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

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Exelixis

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All Subjects

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-833923

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

Etopophos®, Toposar®, VePesid®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

NCI - National Cancer Institute CTCAE - Common Terminology Criteria for Adverse Events MTD - Maximum tolerated dose DLT - Dose limiting toxicity

Time Frame

28 days

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Local Institution

City

East Bentleigh

State/Province

Victoria

ZIP/Postal Code

3165

Country

Australia

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Local Institution

City

Villejuif Cedex

ZIP/Postal Code

94800

Country

France

Facility Name

Local Institution

City

Dublin

Country

Ireland

12. IPD Sharing Statement

Learn more about this trial

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

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