Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 cancer
Started Nov 2011
Shorter than P25 for phase_1 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJune 3, 2013
May 1, 2013
1 year
August 4, 2011
May 31, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Within the first 28 days of treatment
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Up to 90 days additional treatment period plus 60 days of follow-up
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Arm 1: BMS-833923 (XL139)
EXPERIMENTALInterventions
Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Kashiwa-shi, Chiba, 2778577, Japan
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 10, 2011
Study Start
November 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 3, 2013
Record last verified: 2013-05