A Study of BBI503 in Adult Patients With Advanced Solid Tumors
- Registration Number
- NCT01781455
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
- Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Karnofsky performance status ≥ 70%
- Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
- Females of childbearing potential must have a negative serum pregnancy test
- Aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 1.5 × upper limit of normal (ULN)
- Hemoglobin (Hgb) ≥ 10 g/dl
- Total bilirubin < or equal to 1.5 × ULN
- Creatinine < or equal to 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Absolute neutrophil count < or equal to 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Life expectancy ≥ 3 months
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503
- Surgery within 4 weeks prior to first dose
- Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection and small intestinal resection)
- Unable or unwilling to swallow BBI503 capsules daily
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BBI503 BBI503 -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events as a Measure of Safety and Tolerability Adverse events will be assessed at baseline, while the participant is taking BBI503, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months. Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.
Determination of the recommended Phase 2 dose Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks
- Secondary Outcome Measures
Name Time Method Anti-tumor activity Participants will be assessed every eight weeks for anti-tumor activity. To assess the preliminary anti-tumor activity of BBI503.
Pharmacokinetic profile (Area under the curve) of BBI503 During the first 28 days of treatment Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI503.
Pharmacodynamic activity During the first 28 days of treatment Tumor Biopsy(s) to provide information on analysis of the targets and downstream genes/ effect of BBI503 on cancer stem cells through immunohistochemistry.
Trial Locations
- Locations (19)
Texas Oncology- Tyler
🇺🇸Tyler, Texas, United States
Institute for Translational Oncology Research, Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Texas Oncology- Fort Worth
🇺🇸Fort Worth, Texas, United States
Mayo Clinic Cancer Center, Scottsdale
🇺🇸Scottsdale, Arizona, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Yakima Memorial Hostpial/North Star Lodge
🇺🇸Yakima, Washington, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Virginia Cancer Specialists, P.C.
🇺🇸Fairfax, Virginia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Cancer Care Centers of South Texas - HOAST
🇺🇸San Antonio, Texas, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center, Rochester
🇺🇸Rochester, Minnesota, United States
Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States