A Study of BBI608 in Adult Patients With Advanced Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boston Biomedical, Inc
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc
ClinicalTrials.gov Identifier:
NCT01775423
First received: January 17, 2013
Last updated: October 24, 2014
Last verified: September 2014
  Purpose

This is an open label, single arm, dose escalation study of BBI608 in patients with advanced malignancies.


Condition Intervention Phase
Cancer, Advanced Malignancies
Drug: BBI608
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of BBI608 in Adult Patients With Advanced Malignancies

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 BBI608, 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 BBI608 given in monotherapy to patients with advanced malignancies by reporting of adverse events and serious adverse events


Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBI608 Drug: BBI608

  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 Harmonisation (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. For solid tumors or lymphoma, 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. For solid tumors, measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  5. For lymphoma, measurable disease as defined by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma
  6. For multiple myeloma, measurable disease as defined by the International Uniform Response Criteria for Multiple Myeloma
  7. Karnofsky performance status greater than or equal to 70%
  8. 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 BBI608 dose
  9. Females of childbearing potential must have a negative serum pregnancy test
  10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5 × upper limit of normal(ULN)
  11. Hemoglobin (Hgb) greater than or equal to 10 g/dl
  12. Total bilirubin less than or equal to 1.5 × ULN
  13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Creatinine < 2.5 x ULN for multiple myeloma patients.
  14. Absolute neutrophil count greater than or equal to 1.5 x 109/L
  15. Platelets greater than or equal to 100 x 109/L
  16. Life expectancy greater than or equal to 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 BBI608.
  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 and small intestine resection)
  6. Unable or unwilling to swallow BBI608 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: NCT01775423

Contacts
Contact: Boston Biomedical 617-674-6800

Locations
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         
Canada, Ontario
Ottawa Hospital Cancer Center Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Derek Jonker, MD    613-737-7700      
Principal Investigator: Derek Jonker, MD         
Canada, Quebec
Jewish General Hospital Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Boston Biomedical, Inc
  More Information

No publications provided

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT01775423     History of Changes
Other Study ID Numbers: BBI608-101
Study First Received: January 17, 2013
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014