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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Herbert Hurwitz
Study ID
NCT00586092
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab, ABT-510 — DRUG
    * 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.

Study Details

The primary objective of this study is to determine the recommended Phase II dose for the combination of ABT-510 plus bevacizumab in patients with advanced solid tumors and to evaluate dose limiting toxicities and non-dose limiting toxicities of this combination. The secondary objectives are to collect preliminary data on the effect of the combination of ABT-510 plus bevacizumab versus each agent individually on dermal wound angiogenesis in a skin biopsy and to collect preliminary data on the clinical activity of this combination (tumor response rate, progression-free survival, rate of stable disease \> 6 months).

Key Dates

First listed
Jan 4, 2008
Start date
Sep 30, 2005
Status verified
Apr 2013
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP

Arms

  • Other: 1
    This trial employs a phase I design with a dose escalation stage (stage I) and an expansion stage (stage 2) to better describe the tolerability of this combination and the effect of this combination on several biomarkers. In this second stage there will be two groups, each with ten patients, to better describe the tolerability of the bevacizumab/ABT-510 combination and the effect of this combination on several biomarkers. The primary objective of this study is to estimate the MTD/recommended phase II dose regimen. All other objectives are exploratory in nature.

Primary Outcome Measure

To determine the recommended Phase II dose for the combination of ABT-510 plus bevacizumab [ Time Frame: Each Cycle (28-days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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