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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum-tolerated dose and dose-limiting toxicity of AEE788

Outcome Time Frame:

4.5 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAEE788A2101

NCT ID:

NCT00118456

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Cancer
  • Advanced cancers
  • EGFR
  • Her2
  • VEGFR
  • Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Nevada Cancer InstituteLas Vegas, Nevada  89135
Sarah Cannon Research InstituteNashville, Tennessee  37203
Institute of Drug Development/Cancer Therapy and Research CenterSan Antonio, Texas  78229