A Study of BBI503 in Adult Patients With Advanced Solid Tumors

NCT ID: NCT01781455

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2020-06-30

Brief Summary

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

Conditions

Cancer, Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BBI503

Group Type: EXPERIMENTAL

BBI503

Intervention Type: DRUG

Interventions

BBI503

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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.

3. ≥ 18 years of age

4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

5. Karnofsky performance status ≥ 70%

6. 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

7. Females of childbearing potential must have a negative serum pregnancy test

8. Aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 1.5 × upper limit of normal (ULN)

9. Hemoglobin (Hgb) ≥ 10 g/dl

10. Total bilirubin < or equal to 1.5 × ULN

11. 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

12. Absolute neutrophil count < or equal to 1.5 x 10^9/L

13. Platelets ≥ 100 x 10^9/L

14. Life expectancy ≥ 3 months

Exclusion Criteria

1. 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

2. Surgery within 4 weeks prior to first dose

3. 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.

4. Pregnant or breastfeeding

5. 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)

6. Unable or unwilling to swallow BBI503 capsules daily

7. 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

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

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Canada

Other Identifiers

BBI503-101

Identifier Type: -

Identifier Source: org_study_id