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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

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

Treatments: Drug: BMS-833923 (XL139)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670189

CA194-002

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

• 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 Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

BMS-833923

Experimental group

Treatment:

Drug: BMS-833923 (XL139)