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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01360554
First received: April 12, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer (NSCLC) |
Drug: Dacomitinib (PF-00299804) Drug: Active Comparator (erlotinib) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Progression Free Survival per Independent Radiologic review in two co-primary populations. [ Time Frame: 10 months after anticipated LSLV ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 800 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
|
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)
|
|
Active Comparator: B
Blinded active comparator (erlotinib) + blinded placebo 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360554
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| United States, Alabama | |
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| Birmingham, Alabama, United States, 35233 | |
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| Birmingham, Alabama, United States, 35249 | |
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| Birmingham, Alabama, United States, 35294 | |
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| Florence, Alabama, United States, 35630 | |
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| Mobile, Alabama, United States, 36617 | |
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| Chandler, Arizona, United States, 85224 | |
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| United States, Arkansas | |
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| Alhambra, California, United States, 91801 | |
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| Bakersfield, California, United States, 93309 | |
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| Duarte, California, United States, 91010 | |
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| Fullerton, California, United States, 92835 | |
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| Los Angeles, California, United States, 90095-1772 | |
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| Los Angeles, California, United States, 90095 | |
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| Pasadena, California, United States, 91107 | |
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| Ocala, Florida, United States, 34471 | |
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| St. Louis, Missouri, United States, 63110 | |
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| St. Peters, Missouri, United States, 63376 | |
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| Bruxelles, Belgium, 1200 | |
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| Charleroi, Belgium, 6000 | |
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| Roeselare, Belgium, 8800 | |
| China, Guangxi | |
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| Nanning, Guangxi, China, 530021 | |
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| Wuhan, Hubei, China, 430023 | |
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| Shanghai, China, 200433 | |
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| Aaborg, Denmark, 9100 | |
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| HUS, Finland, 00029 | |
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| Pori, Finland, 28500 | |
| France | |
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| Dijon, France, 21079 | |
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| Grenoble Cedex 09, France, 38043 | |
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| Paris, France, 75014 | |
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| Poitiers Cedex, France, 86021 | |
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| ST HERBLAIN cedex, France, 44805 | |
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| Toulouse cedex 9, France, 31059 | |
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| Aachen, Germany, 52074 | |
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| Dresden, Germany, 01307 | |
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| Mainz, Germany, 55131 | |
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| Moers, Germany, 47441 | |
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| Nuernberg, Germany, 90419 | |
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| Heraklion, Crete, Greece, 71110 | |
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| Athens, Greece, 115 27 | |
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| Larissa, Greece, 41110 | |
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| Budapest, Hungary, 1125 | |
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| Farkasgyepu, Hungary, 8582 | |
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| Torokbalint, Hungary, 2045 | |
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| Zalaegerszeg-Pozva, Hungary, 8900 | |
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| Bangalore, Karnataka, India, 560 017 | |
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| Mumbai, Maharashtra, India, 400012 | |
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| Pune, Maharastra, India, 411 001 | |
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| Okayama-city, Okayama, Japan | |
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| Osakasayama-shi, Osaka, Japan | |
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| Sunto-gun, Shizuoka, Japan | |
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| Chuo-Ku, Tokyo, Japan | |
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| Ube-shi, Yamaguchi, Japan | |
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| Fukuoka, Japan | |
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| Koto-ku, Tokyo, Japan | |
| Korea, Republic of | |
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| Seoul, Korea, Republic of, 110-744 | |
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| Seoul, Korea, Republic of, 135-710 | |
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| Seoul, Korea, Republic of, 138-736 | |
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| Oaxaca, Mexico, 68000 | |
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| Otwock, Poland, 05-400 | |
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| Warszawa, Poland, 02-781 | |
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| Warszawa, Poland, 00-728 | |
| Russian Federation | |
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| Krasnodar, Krasnodar region, Russian Federation, 350012 | |
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| Lermontov, Stavropol Territory, Russian Federation, 357340 | |
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| Nitra, Slovakia, 949 88 | |
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| Nove Zamky, Slovakia, 940 34 | |
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| Bloemfontein, South Africa, 9301 | |
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| Port Elizabeth, South Africa, 6045 | |
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| Elche, Alicante, Spain, 03203 | |
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| Badalona, Barcelona, Spain, 08916 | |
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| Barcelona, Spain, 08041 | |
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| Castellon, Spain, 12002 | |
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| Sevilla, Spain, 41013 | |
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| Karlstad, Sweden, 651 85 | |
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| Stockholm, Sweden, 171 76 | |
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| Aarau, Switzerland, 5001 | |
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| Bellinzona, Switzerland, 6500 | |
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| Geneva, Switzerland, 1211 | |
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| St. Gallen, Switzerland, 9007 | |
| United Kingdom | |
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| London, Edmonton, United Kingdom, N18 1QX | |
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| Maidstone, Kent, United Kingdom, ME16 9QQ | |
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| Wolverhampton, West Midlands, United Kingdom, WV10 0QP | |
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| Leicester, United Kingdom, LE1 5WW | |
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| London, United Kingdom, NW1 2PQ | |
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| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01360554 History of Changes |
| Other Study ID Numbers: | A7471009 |
| Study First Received: | April 12, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
comparative study of PF-00299804 and Erlotinib Double-Blind Phase 3 trial of TKI |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013