A Phase I Study of ABT-510 in Combination With Bevacizumab in Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

February 28, 2013

Study Completion Date

February 28, 2013

Conditions
Solid Tumors
Interventions
DRUG

bevacizumab, ABT-510

"* Stage 1 (Cohorts -1, 2, 2, 3) ABT-510: 25, 50, 50, 100 mg SC BID\*, bevacizumab: 5, 5, 10, 10 mg/kg IV every 14 days\*~* Stage 2 (RPTD) ABT-510: X mg SC BID\*\*, bevacizumab: Y mg/kg IV every 14 days\*\*~ * Stage I is the dose escalation stage. Stage II will include an additional 20 patients (10 patients in each group) enrolled at the RPTD in two different schedules to better assess safety and biomarker correlates.~ * \*Both agents begin on Day 1 of Cycle 1.~ * \*\*At the RPTD, ½ the patients will begin ABT-510 (Dose X) on Day 1 and bevacizumab (Dose Y) on Day 15 and the other ½ of the patients will begin bevacizumab on Day 1 and ABT-510 on Day 15. This will allow for a collection of some preliminary data of wound angiogenesis effects of ABT-510 alone versus the combination and bevacizumab alone versus the combination."

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Abbott

INDUSTRY

lead

Herbert Hurwitz

OTHER