A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
Basic Trial Information
|Phase II||Biomarker/Laboratory analysis, Treatment||Active||18 and over||BBI608-224|
This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab,
panitumumab or capecitabine in patients with advanced colorectal cancer.
Further Study Information
This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with
either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and
continuous oral administration of BBI608 for four weeks in combination with either cetuximab,
or panitumumab, or capecitabine.
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.
A histologically or cytologically confirmed colorectal cancer that is metastatic,
unresectable, or recurrent.
Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin,
Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have
colorectal cancer which is K-Ras wild-type.
≥ 18 years of age.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST
Karnofsky performance Status ≥ 70%
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
Females of childbearing potential must have a negative serum pregnancy test.
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of
normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease.
Hemoglobin (Hgb) ≥ 10 g/dl.
Total bilirubin ≤ 1.5 × ULN.
Creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with
creatinine levels above institutional normal.
Absolute neutrophil count ≥ 1.5 x 10^9/L.
Platelets ≥ 100 x 10^9/L.
Life expectancy ≥ 3 months.
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.
Surgery within 4 weeks prior to first dose.
Any known symptomatic brain metastases requiring steroids. Patients with treated brain
metastases 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.
Pregnant or breastfeeding
Significant gastrointestinal disorder(s), in the opinion of the Principal
Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small
Unable or unwilling to swallow BBI608 capsules daily.
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
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Boston Biomedical, Inc
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01776307
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.