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Study of Oral AEE788 in Adults With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00118456
First received: July 1, 2005
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Single dose and repeated dose pharmacokinetic profile of AEE788 [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  • Changes in glucose metabolism/cell viability [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00118456     History of Changes
Other Study ID Numbers: CAEE788A2101
Study First Received: July 1, 2005
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Advanced cancers
EGFR
Her2
VEGFR

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013