A Study of BBI503 in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781455
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Last Update Posted : April 3, 2018
Information provided by (Responsible Party):
Boston Biomedical, Inc

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

Condition or disease Intervention/treatment Phase
Cancer, Advanced Solid Tumors Drug: BBI503 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors
Study Start Date : February 2012
Estimated Primary Completion Date : December 2018

Arm Intervention/treatment
Experimental: BBI503 Drug: BBI503

Primary Outcome Measures :
  1. Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.

  2. Determination of the recommended Phase 2 dose [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile (Area under the curve) of BBI503 [ Time Frame: During the first 28 days of treatment ]
    Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI503.

  2. Pharmacodynamic activity [ Time Frame: 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.

  3. Anti-tumor activity [ Time Frame: Participants will be assessed every eight weeks for anti-tumor activity. ]
    To assess the preliminary anti-tumor activity of BBI503.

Other Outcome Measures:
  1. Progression Free Survival [ Time Frame: The time the participant stays on study until progression will be measured and recorded. This is estimated to be approximately 4 months. ]
  2. Overall Survival [ Time Frame: 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. ]
    The time of overall survival will be measured and recorded for each participant.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781455

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

Responsible Party: Boston Biomedical, Inc Identifier: NCT01781455     History of Changes
Other Study ID Numbers: BBI503-101
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018