NCT00225121

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
18 days until next milestone

Study Start

First participant enrolled

October 11, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2007

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2010

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

September 21, 2005

Last Update Submit

December 19, 2018

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Safety

    6 months

Secondary Outcomes (3)

  • Pharmacokinetics

    6 months

  • Pharmacodynamics

    6 months

  • Efficacy

    6 months

Study Arms (1)

1

EXPERIMENTAL

open label single arm trial

Drug: PF-00299804

Interventions

PF-00299804DRUG

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

1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

Location

UCLA Oncology Center

Los Angeles, California, 90095, United States

Location

UCLA Hematology Oncology - Santa Monica

Santa Monica, California, 90404, United States

Location

UCLA Santa Monica Hematology/Oncology

Santa Monica, California, 90404, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Vereniging het Nederlandse Kanker Instituut

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21220471DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

dacomitinib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

October 11, 2005

Primary Completion

April 3, 2007

Study Completion

September 23, 2010

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

NL(1)US(8)