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

NCT00586092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-04-08

No results posted yet for this study

Summary

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).

Conditions

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Herbert Hurwitz

    lead OTHER

Principal Investigators

  • Herb Hurwitz, MD · Duke University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00586092 on ClinicalTrials.gov