Phase I Ascending Multiple-Dose Study of BMS-986115 in Subjects With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Various Advanced Cancer

Treatments: Drug: BMS-986115

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986218

CA002-001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Arm A: Dose Escalation (BMS-986115)

Experimental group

Description:

Continuous daily dosing until disease progression or unacceptable toxicity

Treatment:

Drug: BMS-986115

Arm A: Dose Expansion (BMS-986115)

Experimental group

Description:

Continuous daily dosing until disease progression or unacceptable toxicity

Treatment:

Drug: BMS-986115

Arm B: Dose Escalation (BMS-986115)

Experimental group

Description:

Twice weekly dosing until disease progression or unacceptable toxicity

Treatment:

Drug: BMS-986115

Arm B: Dose Expansion (BMS-986115)

Experimental group

Description:

Twice weekly dosing until disease progression or unacceptable toxicity

Treatment:

Drug: BMS-986115