NCT00927875

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2.6 years

First QC Date

June 9, 2009

Last Update Submit

May 31, 2013

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

Study Arms (1)

All Subjects

EXPERIMENTAL
Drug: BMS-833923Drug: CarboplatinDrug: Etoposide

Interventions

BMS-833923DRUG

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

All Subjects
CarboplatinDRUG

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

Also known as: Paraplatin®
All Subjects
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

Also known as: Etopophos®, Toposar®, VePesid®
All Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Local Institution

East Bentleigh, Victoria, 3165, Australia

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Villejuif, 94800, France

Location

Local Institution

Dublin, Dublin, Ireland

Location

Related Links

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

BMS-833923CarboplatinEtoposideetoposide phosphate

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 25, 2009

Study Start

February 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

IE(1)FR(1)AU(1)US(1)CA(2)