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:
Bristol-Myers Squibb
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00927875
First received: June 9, 2009
Last updated: May 15, 2013
Last verified: May 2013
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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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927875
Locations
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, North Carolina | |
| University Of North Carolina At Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| 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 15, 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:
|
Carcinoma Lung Neoplasms Small Cell Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Etoposide Etoposide phosphate Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013