A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer

Completed · Phase 1

Conditions studied: Hedgehog Pathway, Smoothened, Basal Cell Carcinoma (BCC), Basal Cell Nevoid Syndrome (BCNS)

In brief

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

Key facts

Study ID

NCT00670189

Run by

Bristol-Myers Squibb

People needed

53

Starts

2008-07-01

Expected to finish

2014-05-01

Last updated by the study team

2014-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Southwest Texas Addiction Research And Tech (Start) Center — San Antonio, Texas, United States
• Local Institution — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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