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Study of Oral AEE788 in Adults With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118456
First Posted: July 11, 2005
Last Update Posted: January 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.

Condition Intervention Phase
Cancer Drug: AEE788 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Multicenter, Randomized Dose-Escalation Study of Oral AEE788 on Intermittent Dosing Schedules in Adult Patients With Advanced Cancer (Effective Amendment 5) Previously Entitled A Phase IA, Multicenter, Dose-Escalating Study of Oral AEE788 on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Cancer

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Maximum-tolerated dose and dose-limiting toxicity of AEE788 [ Time Frame: 4.5 years ]
  • Maximum-tolerated dose, safety and tolerability of AEE788 [ Time Frame: 4.5 years ]

Secondary Outcome Measures:
  • Single dose and repeated dose pharmacokinetic profile of AEE788 [ Time Frame: 4.5 years ]
  • Pharmacodynamic effects [ Time Frame: 4.5 years ]
  • Changes in glucose metabolism/cell viability [ Time Frame: 4.5 years ]

Enrollment: 189
Study Start Date: July 2003
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Continuous daily dosing
Drug: AEE788
Experimental: 2
Monday, Wednesday, Friday Dosing
Drug: AEE788

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Histologically confirmed solid tumor
  • Adequate hematologic, renal and hepatic function
  • Age ≥ 18 years
  • Karnofsky performance status score ≥ 70%
  • Life expectancy ≥ 12 weeks

Exclusion Criteria:

  • Active brain metastases
  • Peripheral neuropathy > grade 2
  • Diarrhea > grade 1
  • Gastrointestinal (GI) dysfunction
  • Compromised cardiac function
  • Concurrent severe and/or uncontrolled medical conditions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118456


Locations
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89125
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77054
Institute of Drug Development/Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00118456     History of Changes
Other Study ID Numbers: CAEE788A2101
First Submitted: July 1, 2005
First Posted: July 11, 2005
Last Update Posted: January 9, 2012
Last Verified: January 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced cancers
EGFR
Her2
VEGFR