We're sorry, but this trial is no longer enrolling volunteers.
0C-14-3: Phase I Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-986115 in Subjects with Advanced Solid Tumors
The primary purpose of this study is to evaluate the safety and effectiveness of daily doses
of BMS-986115 in subjects with advanced solid tumors
Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.
Inclusion and Exclusion Criteria
- Subjects with a histologically or cytologically confirmed diagnosis of solid tumors, advanced or metastatic, refractory to or relapsed from standard therapies or for which there is no known effective treatment
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
- Prior anti-cancer treatments are permitted (i.e., chemotherapy, radiotherapy, hormonal, or immunotherapy)
- At least 4 weeks must have elapsed from last dose of prior anti-cancer therapy and the initiation of study therapy
- Subjects with known or suspected brain metastases, primary brain tumors, or brain as the only site of disease
- Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication
- Current or recent (within 3 months of study drug administration) gastrointestinal disease such as chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease. Non-chronic conditions (e.g. infectious diarrhea) that are completely resolved for at least 2 weeks prior to starting study treatment are not exclusionary
- Any major surgery or gastrointestinal disease that would interfere with administration of oral medications
- Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.
- Uncontrolled or significant cardiovascular disease
- History of medically significant thromboembolic events or bleeding diathesis within the past 6 months
- Inadequate bone marrow function (Absolute neutrophil count (ANC) < 1,500 cells/mm3; Platelet count < 100,000 cells/mm3; Hemoglobin < 9.0 g/dL)
- Inadequate hepatic function (Total bilirubin > 1.5 times the institutional upper limit of normal (ULN) (except known Gilbert's syndrome); Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the institutional ULN. ALT or AST up to 3 times the institutional ULN permitted if total bilirubin is normal
- Uncontrolled (≥ Grade 2) hypertriglyceridemia (fasting triglycerides > 300 mg/dL (3.42 mmol/L))
- Inadequate renal function (Blood creatinine > 1.5 times the institutional ULN)
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV) -1, -2 antibody
- Usc/Norris Comprehensive Cancer Center, Los Angeles, California, 90033