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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Genentech
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00754104
First received: September 15, 2008
Last updated: January 17, 2011
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: ABT-869
Drug: Tarceva
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Day 7, 15, 21, 35 and Day 1 of every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: ABT-869
0.25 mg/kg. daily.
Other Name: ABT-869
Drug: Tarceva
150mg, daily.
Other Name: Tarceva

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Rod Humerickhouse, Global Project Head, Oncology, Abbott
ClinicalTrials.gov Identifier: NCT00754104     History of Changes
Other Study ID Numbers: M10-371
Study First Received: September 15, 2008
Last Updated: January 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014