A Study of BBI503 in Adult Patients With Advanced Solid Tumors

Cancer, Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781455
• Other study ID #: BBI503-101
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Est. completion date: June 2020

Study information

• Verified date: November 2023
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• BBI503

Locations

Country	Name	City	State
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Virginia Cancer Specialists, P.C.	Fairfax	Virginia
United States	Texas Oncology- Fort Worth	Fort Worth	Texas
United States	Institute for Translational Oncology Research, Greenville Hospital System	Greenville	South Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Mayo Clinic Cancer Center, Rochester	Rochester	Minnesota
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Cancer Care Centers of South Texas - HOAST	San Antonio	Texas
United States	Mayo Clinic Cancer Center, Scottsdale	Scottsdale	Arizona
United States	Texas Oncology- Tyler	Tyler	Texas
United States	Yakima Memorial Hostpial/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression Free Survival		The time the participant stays on study until progression will be measured and recorded. This is estimated to be approximately 4 months.
Other	Overall Survival	The time of overall survival will be measured and recorded for each participant.	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.
Primary	Number of participants with Adverse Events as a Measure of Safety and Tolerability	Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.	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.
Primary	Determination of the recommended Phase 2 dose		Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks
Secondary	Pharmacokinetic profile (Area under the curve) of BBI503	Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI503.	During the first 28 days of treatment
Secondary	Pharmacodynamic activity	Tumor Biopsy(s) to provide information on analysis of the targets and downstream genes/ effect of BBI503 on cancer stem cells through immunohistochemistry.	During the first 28 days of treatment
Secondary	Anti-tumor activity	To assess the preliminary anti-tumor activity of BBI503.	Participants will be assessed every eight weeks for anti-tumor activity.