Cancer
Conditions
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.
Interventions
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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose Limiting Toxicity (DLT) and observed adverse events | Within the first 28 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The number of subjects experienced DLT | Within the first 28 days |
| 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 |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139) | Day1 and Day 29 |
Countries
Japan
Outcome results
None listed