A Study of BBI503 in Adult Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Cancer, Advanced Solid Tumors

In brief

This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.

Key facts

Study ID

NCT01781455

Run by

Sumitomo Pharma America, Inc.

People needed

311

Starts

2012-02-01

Expected to finish

2020-06-01

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Cancer Center, Scottsdale — Scottsdale, Arizona, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Indiana University — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic Cancer Center, Rochester — Rochester, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Institute for Translational Oncology Research, Greenville Hospital System — Greenville, South Carolina, United States
• Texas Oncology- Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology- Fort Worth — Fort Worth, Texas, 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
• Texas Oncology- Tyler — Tyler, Texas, United States
• Virginia Cancer Specialists, P.C. — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Yakima Memorial Hostpial/North Star Lodge — Yakima, Washington, United States
• Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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