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

NCT ID: NCT00225121

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-11

Study Completion Date

2010-09-23

Brief Summary

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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

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Conditions

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Neoplasms

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

open label single arm trial

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

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

Interventions

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PF-00299804

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

UCLA Hematology/Oncology

Los Angeles, California, United States

Site Status

UCLA Oncology Center

Los Angeles, California, United States

Site Status

UCLA Hematology Oncology - Santa Monica

Santa Monica, California, United States

Site Status

UCLA Santa Monica Hematology/Oncology

Santa Monica, California, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Vereniging het Nederlandse Kanker Instituut

Amsterdam, , Netherlands

Site Status

Countries

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United States Netherlands

References

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Janne PA, Boss DS, Camidge DR, Britten CD, Engelman JA, Garon EB, Guo F, Wong S, Liang J, Letrent S, Millham R, Taylor I, Eckhardt SG, Schellens JH. Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin Cancer Res. 2011 Mar 1;17(5):1131-9. doi: 10.1158/1078-0432.CCR-10-1220. Epub 2011 Jan 10.

Reference Type DERIVED
PMID: 21220471 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471001&StudyName=Study%20To%20Evaluate%20The%20Safety%2C%20Pharmacokinetics%2C%20And%20Pharmacodynamics%20Of%20PF-00299804%20In%20Patients%20With%20Advanced%20Solid%20Tumors

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Other Identifiers

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2005-001140-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A7471001

Identifier Type: -

Identifier Source: org_study_id

NCT00276653

Identifier Type: -

Identifier Source: nct_alias

NCT00278291

Identifier Type: -

Identifier Source: nct_alias