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

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ClinicalTrials.gov Identifier: NCT00754104
Recruitment Status : Withdrawn
First Posted : September 17, 2008
Last Update Posted : January 19, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ABT-869 Drug: Tarceva Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy
Study Start Date : September 2008
Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: ABT-869
0.25 mg/kg. daily.
Drug: Tarceva
150mg, daily.


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Day 7, 15, 21, 35 and Day 1 of every 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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%.
More Information

Responsible Party: Rod Humerickhouse, Global Project Head, Oncology, Abbott
ClinicalTrials.gov Identifier: NCT00754104     History of Changes
Other Study ID Numbers: M10-371
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2009

Additional relevant MeSH terms:
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action