Clinical trial NCT01781455: A Study of BBI503 in Adult Patients With Advanced Solid Tumors
Official title: A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer, Advanced Solid Tumors
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.


Eligibility criteria: 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)
5. Karnofsky performance status ≥ 70%
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 m\^2 for patients with creatinine levels above institutional normal
12. Absolute neutrophil count \< or equal to 1.5 x 10\^9/L
13. Platelets ≥ 100 x 10\^9/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

Primary outcomes:
measure: Number of participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 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.
measure: Determination of the recommended Phase 2 dose
timeFrame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks
Secondary outcomes:
measure: Pharmacokinetic profile (Area under the curve) of BBI503
timeFrame: During the first 28 days of treatment
measure: Pharmacodynamic activity
timeFrame: During the first 28 days of treatment
measure: Anti-tumor activity
timeFrame: Participants will be assessed every eight weeks for anti-tumor activity.
Other outcomes:
measure: Progression Free Survival
timeFrame: The time the participant stays on study until progression will be measured and recorded. This is estimated to be approximately 4 months.
measure: Overall Survival
timeFrame: Participant follow-up for overall survival will occur approximately quarterly for the first year the participant is off study, twice during the second year, and once per year thereafter for up to approximately 100 months.
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Cancer Center, Scottsdale
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center, Rochester
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Greenville
country: United States
facility: Institute for Translational Oncology Research, Greenville Hospital System
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology- Fort Worth
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas - HOAST
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Tyler
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, P.C.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Yakima
country: United States
facility: Yakima Memorial Hostpial/North Star Lodge
state: Washington
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
References: