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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Boston Biomedical, Inc
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc
ClinicalTrials.gov Identifier:
NCT01781455
First received: January 24, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Cancer, Advanced Solid Tumors
Drug: BBI503
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Boston Biomedical, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.

  • Determine recommended Phase 2 dose [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the pharmacokinetic profile (Area under the curve) of BBI503 [ Time Frame: During the first 28 days of treatment ] [ Designated as safety issue: No ]
    Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI503.

  • Assess pharmacodynamic activity [ Time Frame: During the first 28 days of treatment ] [ Designated as safety issue: No ]
    Tumor Biopsy(s) to provide information on analysis of the targets and downstream genes/ effect of BBI503 on cancer stem cells through immunohistochemistry.

  • Anti-tumor activity [ Time Frame: Participants will be assessed every eight weeks for anti-tumor activity. ] [ Designated as safety issue: No ]
    To assess the preliminary anti-tumor activity of BBI503.


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    The time of overall survival will be measured and recorded for each participant.


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBI503 Drug: BBI503

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, see Section 9)
  5. Karnofsky performance status ≥ 70% (Section 14)
  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 m2 for patients with creatinine levels above institutional normal
  12. Absolute neutrophil count < or equal to 1.5 x 109/L
  13. Platelets ≥ 100 x 109/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781455

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Siobhan Collins    617-632-2580    Siobhan_Collins@dfci.harvard.edu   
Principal Investigator: Joyce F. Liu, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kelly Vitale    617-724-2578    kvitale3@mgh.harvard.edu   
Principal Investigator: Gregory M. Cote, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kimiko Kossler    617-632-9280    PhaseIOncologyTrials@bidmc.harvard.edu   
Principal Investigator: James W. Mier, MD         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: The University of Michigan Cancer AnswerLine    800-865-1125      
Principal Investigator: David C Smith, MD         
United States, South Carolina
Institute for Translational Oncology Research, Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jan Kueber, RN    864-455-3600    jkueber@ghs.org   
Principal Investigator: William J Edenfield, MD         
Sub-Investigator: Joe J Stephenson, MD         
Canada, Ontario
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Laurie, MD    613-737-7700      
Principal Investigator: Scott Laurie, MD         
Sub-Investigator: Derek Jonker, MD         
Sponsors and Collaborators
Boston Biomedical, Inc
Investigators
Principal Investigator: William J Edenfield, MD Greenville Hospital System, ITOR
Principal Investigator: Scott Laurie, MD Ottawa Hospital Cancer Centre
  More Information

No publications provided

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT01781455     History of Changes
Other Study ID Numbers: BBI503-101
Study First Received: January 24, 2013
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014