A Study of BBI503 in Adult Patients With Advanced Solid Tumors

A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors

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

Study Overview

• Status: Completed
• Conditions: Cancer, Advanced Solid Tumors
• Intervention / Treatment: Drug: BBI503

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Cancer Centre
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Cancer Center, Scottsdale
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center, Rochester
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Institute for Translational Oncology Research, Greenville Hospital System
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology- Baylor Charles A. Sammons Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology- Fort Worth
    • San Antonio, Texas, United States, 78217
      • Cancer Care Centers of South Texas
    • San Antonio, Texas, United States, 78229
      • Cancer Care Centers of South Texas - HOAST
    • Tyler, Texas, United States, 75702
      • Texas Oncology- Tyler
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, P.C.
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Yakima, Washington, United States, 98902
      • Yakima Memorial Hostpial/North Star Lodge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBI503	Drug: BBI503

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile (Area under the curve) of BBI503	Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI503.	During the first 28 days of treatment
Pharmacodynamic activity	Tumor Biopsy(s) to provide information on analysis of the targets and downstream genes/ effect of BBI503 on cancer stem cells through immunohistochemistry.	During the first 28 days of treatment
Anti-tumor activity	To assess the preliminary anti-tumor activity of BBI503.	Participants will be assessed every eight weeks for anti-tumor activity.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The time of overall survival will be measured and recorded for each participant.	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.

Collaborators and Investigators

• Sponsor: Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimated): February 1, 2013

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BBI503-101