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OpenTrials
Completed

NCT Number: NCT00118456

Study of Oral AEE788 in Adults With Advanced Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale Cancer Center, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEE788

Drug

Primary outcomes

  1. Maximum-tolerated dose and dose-limiting toxicity of AEE788

    Time frame: 4.5 years

  2. Maximum-tolerated dose, safety and tolerability of AEE788

    Time frame: 4.5 years

Secondary outcomes

  1. Single dose and repeated dose pharmacokinetic profile of AEE788

    Time frame: 4.5 years

  2. Pharmacodynamic effects

    Time frame: 4.5 years

  3. Changes in glucose metabolism/cell viability

    Time frame: 4.5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
First posted
Jul 11, 2005
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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