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Clinical Trials/NCT00225121
NCT00225121CompletedPhase 1

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

Pfizer9 sites in 2 countries121 target enrollmentStarted: October 11, 2005Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Pfizer
Enrollment
121
Locations
9
Primary Endpoint
Safety
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

open label single arm trial

Intervention: PF-00299804 (Drug)

Outcomes

Primary Outcomes

Safety

Time Frame: 6 months

Secondary Outcomes

  • Pharmacodynamics(6 months)
  • Efficacy(6 months)
  • Pharmacokinetics(6 months)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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