Status:

WITHDRAWN

Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors

Lead Sponsor:

Abbott

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors

Eligibility Criteria

Inclusion

  • Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
  • Subject must have an ECOG Score of 0-2.
  • Adequate organ function.

Exclusion

  • Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
  • Subject has untreated brain or meningeal metastases.
  • History of greater than 10% weight loss.
  • Has clinically relevant hemoptysis.
  • Subject has proteinuria CTC grade \> 1.
  • Must not have had radiation therapy or major surgery within 21 days of study day 1.
  • The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) \> 100 mmHg or systolic blood pressure (SBP) \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
  • The subject has a documented left ventricular ejection fraction (LVEF) \< 50%.

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00754104

Start Date

September 1 2008

Last Update

January 19 2011

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