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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: BMS-833923 (XL139)

• Registration Number: NCT01413906
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: BMS-833923 (XL139)	BMS-833923 (XL139)	-

Primary Outcome Measures

Name	Time	Method
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events	Up to 90 days additional treatment period plus 60 days of follow-up

Secondary Outcome Measures

Name	Time	Method
The number of subjects experienced DLT	Within the first 28 days
Maximum observed concentration (Cmax) of BMS-833923 (XL139)	Day1 and Day 29
Trough observed concentration (Cmin) of BMS-833923 (XL139)	Day1 and Day 29
Time of maximum observed concentration (Tmax) of BMS-833923 (XL139)	Day1 and Day 29
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139)	Day1 and Day 29
Effective half-life (T-half,eff) of BMS-833923 (XL139)	Day1 and Day 29
Accumulation index (AI) of BMS-833923 (XL139)	Day1 and Day 29
Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria	Up to120 days of treatment period

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Kashiwa-shi, Chiba, Japan