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Phase 1/Phase 2
18 Years
Open (Enrolling)
Cancer, Advanced Malignancies

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Trial Information

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

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

Outcome 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.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Cancer, Advanced Malignancies
  • Neoplasms



Institute for Translational Oncology Research, Greenville Hospital System Greenville, South Carolina  29605