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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00225121

Collaborator

(none)

121

Enrollment

Locations

Arm

59.4

Actual Duration (Months)

13.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: PF-00299804	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Oct 11, 2005

Actual Primary Completion Date :

Apr 3, 2007

Actual Study Completion Date :

Sep 23, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 open label single arm trial	Drug: PF-00299804 investigational drug by oral route (escalating doses depending on safety) administered until progression

Arm

Intervention/Treatment

Experimental: 1

open label single arm trial

Drug: PF-00299804

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

Outcome Measures

Primary Outcome Measures

Safety [6 months]

Secondary Outcome Measures

Pharmacokinetics [6 months]
Pharmacodynamics [6 months]
Efficacy [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
2	UCLA Hematology/Oncology	Los Angeles	California	United States	90095
3	UCLA Oncology Center	Los Angeles	California	United States	90095
4	UCLA Hematology Oncology - Santa Monica	Santa Monica	California	United States	90404
5	UCLA Santa Monica Hematology/Oncology	Santa Monica	California	United States	90404
6	University of Colorado Hospital	Aurora	Colorado	United States	80045
7	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
8	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
9	Vereniging het Nederlandse Kanker Instituut	Amsterdam		Netherlands	1066 CX

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00225121

Other Study ID Numbers:

A7471001
2005-001140-23
NCT00276653
NCT00278291

First Posted:

Sep 23, 2005

Last Update Posted:

Dec 21, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Dec 21, 2018