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

This study has been completed.
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00927875
First received: June 9, 2009
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Small Cell Lung Carcinoma
Drug: BMS-833923
Drug: Carboplatin
Drug: Etoposide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    • 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) [ Time Frame: Day 1 and 15 of first three 21-day cycles ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Subjects Drug: BMS-833923
Capsule, Oral, starting dose 30 mg, once daily, continuous
Drug: Carboplatin
Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles
Other Name: Paraplatin®
Drug: Etoposide
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
Other Names:
  • Etopophos®
  • Toposar®
  • VePesid®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927875

Locations
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Australia, Victoria
Local Institution
East Bentleigh, Victoria, Australia, 3165
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
France
Local Institution
Villejuif Cedex, France, 94800
Ireland
Local Institution
Dublin, Ireland
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00927875     History of Changes
Other Study ID Numbers: CA194-005, 2010-018745-56
Study First Received: June 9, 2009
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014