A Study of BBI503 in Adult Patients With Advanced Solid Tumors

NCT01781455 | Completed Phase 1

• 1 other identifier: BBI503-101
• Study Type: interventional
• Target: 311
• Locations: 2 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse Events as a Measure of Safety and Tolerability

  Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.

  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.

• Determination of the recommended Phase 2 dose

  Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks

Secondary Outcomes (3)

• Pharmacokinetic profile (Area under the curve) of BBI503

  During the first 28 days of treatment

• Pharmacodynamic activity

  During the first 28 days of treatment

• Anti-tumor activity

  Participants will be assessed every eight weeks for anti-tumor activity.

Other Outcomes (2)

• Progression Free Survival

  The time the participant stays on study until progression will be measured and recorded. This is estimated to be approximately 4 months.

• Overall Survival

  Participant follow-up for overall survival will occur approximately quarterly for the first year the participant is off study, twice during the second year, and once per year thereafter for up to approximately 100 months.

Study Arms (1)

BBI503

EXPERIMENTAL

Drug: BBI503

Interventions

BBI503 DRUG

BBI503

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (19)

Mayo Clinic Cancer Center, Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Cancer Center, Rochester

Rochester, Minnesota, 55905, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Institute for Translational Oncology Research, Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Texas Oncology- Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology- Fort Worth

Fort Worth, Texas, 76104, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Cancer Care Centers of South Texas - HOAST

San Antonio, Texas, 78229, United States

Location

Texas Oncology- Tyler

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Yakima Memorial Hostpial/North Star Lodge

Yakima, Washington, 98902, United States

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: February 1, 2013
• Study Start: February 1, 2012
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

US (18); CA (1)