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A Study of BBI608 in Adult Patients With Advanced Malignancies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Boston Biomedical, Inc.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775423
First Posted: January 25, 2013
Last Update Posted: October 14, 2015
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.
Information provided by (Responsible Party):
Boston Biomedical, Inc
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of BBI608 in Adult Patients With Advanced Malignancies

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. ]
    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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBI608 Drug: BBI608

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01775423


Locations
United States, South Carolina
Institute for Translational Oncology Research, Greenville Hospital System
Greenville, South Carolina, United States, 29605
Canada, Ontario
Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Boston Biomedical, Inc
  More Information

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT01775423     History of Changes
Other Study ID Numbers: BBI608-101
First Submitted: January 17, 2013
First Posted: January 25, 2013
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Neoplasms