Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid Tumors
- Determine the recommended phase II dose for the combination of ABT-510 plus bevacizumab
in patients with advanced solid tumors.
- Evaluate dose-limiting toxicities and non dose-limiting toxicities of this combination.
- Collect preliminary data on the clinical activity of this combination (tumor response
rate, progression-free survival, and rate of stable disease > 6 months).
OUTLINE: This is a dose-escalation study. Patients are sequentially enrolled with the first
9-18 patients assigned to part 1 and the next 20 patients assigned to part 2 of the study.
- Part 1: Patients receive ABT-510 subcutaneously (SC) twice daily on days 1-28 and
bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of ABT-510 and bevacizumab until the
recommended phase II dose is determined. Patients in part 2 are treated at the recommenced
phase II dose.
- Part 2: The first 10 patients are assigned to group 1. The next 10 patients are
assigned to group 2.
- Group 1: Patients receive ABT-510 SC twice daily beginning on day 1 and
bevacizumab IV once every 14 days beginning on day 15.
- Group 2: Patients receive ABT-510 SC twice daily beginning on day 15 and
bevacizumab IV once every 14 days beginning on day 1.
In both groups, treatment continues in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Primary Purpose: Treatment
Herbert I. Hurwitz, MD
Duke Cancer Institute
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|