Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: BMS-833923 (XL139)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01413906

CA194-010

Details and patient eligibility

About

The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment
• Men and woman, 20 years of age and above

Exclusion criteria

• Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments
• Inability to swallow oral medication
• Uncontrolled or significant cardiovascular disease
• Inadequate bone marrow function
• Inadequate hepatic function
• Inadequate renal function
• Pancreatitis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm 1: BMS-833923 (XL139)

Experimental group

Treatment:

Drug: BMS-833923 (XL139)