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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Genentech, Inc.
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.
Drug: Tarceva
150mg, daily.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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 Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2016