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

NCT ID: NCT01986218

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-03-31

Brief Summary

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

Conditions

Various Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Dose Escalation (BMS-986115)

Continuous daily dosing until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

BMS-986115

Intervention Type: DRUG

Arm A: Dose Expansion (BMS-986115)

Continuous daily dosing until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

BMS-986115

Intervention Type: DRUG

Arm B: Dose Escalation (BMS-986115)

Twice weekly dosing until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

BMS-986115

Intervention Type: DRUG

Arm B: Dose Expansion (BMS-986115)

Twice weekly dosing until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

BMS-986115

Intervention Type: DRUG

Interventions

BMS-986115

Intervention Type: DRUG

Other Intervention Names

BMS-986115 (Notch Inhibitor)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Local Institution

Parkville, Victoria, Australia

Local Institution

Vancouver, British Columbia, Canada

Local Institution

Toronto, Ontario, Canada

Countries

United States; Australia; Canada

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA002-001

Identifier Type: -

Identifier Source: org_study_id