Status:
COMPLETED
A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Exelixis
Conditions:
Hedgehog Pathway
Smoothened
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule
Eligibility Criteria
Inclusion
- For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
- Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma
- Primary or metastatic tumor site accessible for biopsy
- Ability to swallow capsules
- Subjects with histologically confirmed, advanced stage IIIB or stage IV non-small cell lung cancer (NSCLC) with a primary histology of squamous carcinoma who have received prior systemic therapy for advanced NSCLC will be enrolled in Part 3
Exclusion
- Uncontrolled brain metastasis
- Significant cardiovascular disease
- Inadequate blood counts
- Inadequate liver, kidney or lung function
- Gastrointestinal disease within last 3 months
- Infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or exposure to attenuated active immunizations
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00670189
Start Date
July 1 2008
End Date
May 1 2014
Last Update
August 15 2014
Active Locations (3)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
2
Southwest Texas Addiction Research And Tech (Start) Center
San Antonio, Texas, United States, 78229
3
Local Institution
Toronto, Ontario, Canada, M5G 2M9