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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: PF-00299804

• Registration Number: NCT00225121
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-23
• Study Start: 2005-10-11
• Primary Completion: 2007-04-03
• Study Completion: 2010-09-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	PF-00299804	open label single arm trial

Primary Outcome Measures

Name	Time	Method
Safety	6 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	6 months
Pharmacodynamics	6 months
Efficacy	6 months

Trial Locations

Locations (9)

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

UCLA Oncology Center; 🇺🇸 Los Angeles, California, United States

UCLA Hematology Oncology - Santa Monica; 🇺🇸 Santa Monica, California, United States

UCLA Santa Monica Hematology/Oncology; 🇺🇸 Santa Monica, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Vereniging het Nederlandse Kanker Instituut; 🇳🇱 Amsterdam, Netherlands