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Completed

NCT Number: NCT00225121

Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.

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Key information

Conditions

Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vereniging het Nederlandse Kanker Instituut, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Malignant solid tumor for which there is no currently approved treatment
  • Adequate bone marrow, liver, cardiac, and kidney function

Exclusion criteria

  • Cardiac disease
  • Anticancer therapy within 4-6 weeks (depending on therapy)
  • Pregnant or breast-feeding

Treatment and study plan

PF-00299804

Drug

investigational drug by oral route (escalating doses depending on safety) administered until progression

Primary outcomes

  1. Safety

    Time frame: 6 months

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 6 months

  2. Pharmacodynamics

    Time frame: 6 months

  3. Efficacy

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSING SCHEDULES OF PF-00299804 IN PATIENTS WITH ADVANCED MALIGNANT SOLID TUMORS

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
Sep 23, 2005
Registry last updated
Dec 21, 2018

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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