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This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBI503 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBI503 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Determination of the recommended Phase 2 dose | Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pharmacodynamic activity |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| Overall Survival | The time of overall survival will be measured and recorded for each participant. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center, Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| Rocky Mountain Cancer Centers |
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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 |
| Anti-tumor activity | To assess the preliminary anti-tumor activity of BBI503. | Participants will be assessed every eight weeks for anti-tumor activity. |
| 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. |
| Denver |
| Colorado |
| 80218 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Cancer Center, Rochester | Rochester | Minnesota | 55905 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Institute for Translational Oncology Research, Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology- Fort Worth | Fort Worth | Texas | 76104 | United States |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | United States |
| Cancer Care Centers of South Texas - HOAST | San Antonio | Texas | 78229 | United States |
| Texas Oncology- Tyler | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists, P.C. | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Yakima Memorial Hostpial/North Star Lodge | Yakima | Washington | 98902 | United States |
| Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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