ARCHER 1009 : A Study Of PF-00299804 (Dacomitinib) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01360554

First received: April 12, 2011

Last updated: May 31, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2011

Last Updated Date

May 31, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression Free Survival per Independent Radiologic review in two co-primary populations. [ Time Frame: 10 months after anticipated LSLV ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01360554 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: 12 months after anticipated LSLV ] [ Designated as safety issue: No ]
Progression-Free Survival per Investigator [ Time Frame: 4 months after anticipated LSLV ] [ Designated as safety issue: No ]
Best Overall Response [ Time Frame: 6 months after ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: 6 months from LSLV until progression ] [ Designated as safety issue: No ]
Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 months [ Time Frame: until resolution of any unresolved treatment-related adverse event for 6 months from LSLV ] [ Designated as safety issue: Yes ]
Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status [ Time Frame: 6 months from LSLV ] [ Designated as safety issue: No ]
KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline [ Time Frame: baseline, and 12 months from LSLV ] [ Designated as safety issue: No ]
PK trough concentrations [ Time Frame: 12 months from LSLV ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: 12 months after anticipated LSLV ] [ Designated as safety issue: No ]
Progression-Free Survival per Investigator [ Time Frame: 4 months after anticipated LSLV ] [ Designated as safety issue: No ]
Best Overall Response [ Time Frame: 6 months after ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: 6 months from LSLV until progression ] [ Designated as safety issue: No ]
Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 months [ Time Frame: until resolution of any unresolved treatment-related adverse event for 6 months from LSLV ] [ Designated as safety issue: Yes ]
Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status [ Time Frame: 6 months from LSLV ] [ Designated as safety issue: No ]
KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline [ Time Frame: baseline, and 12 months from LSLV ] [ Designated as safety issue: No ]
PK trough concentrations [ Time Frame: 12 months from LSLV ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ARCHER 1009 : A Study Of PF-00299804 (Dacomitinib) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

Official Title ^ICMJE

ARCHER 1009: A Randomized, Double Blind Phase 3 Efficacy and Safety Study Of PF-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-Small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

Brief Summary

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Non-Small Cell Lung Cancer (NSCLC)

Intervention ^ICMJE

Drug: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing + placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.

Other Name: Dacomitinib (PF-00299804)
Drug: Active Comparator (erlotinib)
Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing + placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing.

Study Arm (s)

Experimental: A
Blinded active PF-00299804 + blinded placebo comparator (erlotinib)

Intervention: Drug: Dacomitinib (PF-00299804)
Active Comparator: B
Blinded active comparator (erlotinib) + blinded placebo PF-00299804

Intervention: Drug: Active Comparator (erlotinib)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Evidence of pathologically confirmed, advanced NSCLC (with known histology).
Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).
Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.
Adequate renal, hematologic, liver function.
ECOG PS of 0-2.
Radiologically measurable disease.

Exclusion Criteria:

Small cell histology.
Symptomatic brain mets or known leptomeningeal mets.
Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.
Uncontrolled medical disorders.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01360554

Other Study ID Numbers ^ICMJE

A7471009

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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