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

Phase 1
18 Years
Open (Enrolling)
Cancer, Advanced Solid Tumors

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety 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 BBI503 by reporting of adverse events and serious adverse events.

Outcome 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.

Safety Issue:


Principal Investigator

William J Edenfield, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Greenville Hospital System, ITOR


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Cancer, Advanced Solid Tumors
  • Neoplasms



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