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NCT Number: NCT00927875

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

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).

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Key information

Conditions

Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, East Bentleigh, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-833923

Drug

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

carboplatin

Drug

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

Other names: Paraplatin®

etoposide

Drug

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®

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

    Time frame: 28 days

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Exelixis

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 25, 2009
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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