A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

September 22, 2015 updated by: Pfizer

A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital
      • Geelong, Victoria, Australia, 3220
        • The Andrew Love Cancer Centre,
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, RS, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Fundacao Pio Xii Hospital de Cancer de Barretos
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency - Vancouver Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital
      • Oshawa, Ontario, Canada, L1G 2B9
        • RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Department of Clinical Oncology
      • Tuen Mun, New Territories, Hong Kong
        • Department of Clinical Oncology, Tuen Mun Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
      • Seoul, Korea, Republic of, 135-710
        • SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
  • Poland
      • Chrzanow, Poland, 32-500
        • Medex spolka cywilna
      • Krakow, Poland, 30-045
        • ¿KardioDent¿
      • Krakow, Poland, 31-108
        • "Vesalius" Sp. z o.o.
      • Krakow, Poland, 31-215
        • Zaklad Rentgena i USG Wyrobek spolka jawna
      • Warsaw, Poland, 02-781
        • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
      • Warszawa, Poland, 00-728
        • Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine / CAIMED Center
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • Spain
      • La Coruña, Spain, 15006
        • Hospital Teresa Herrera
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
        • Hospital Son Llàtzer
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces
  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital, Chest Department
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
        • Northwest Alabama Cancer Center
    • California
      • Montebello, California, United States, 90640
        • Agajanian Institute of Oncology and Hematology
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Norwalk, Connecticut, United States, 06856
        • Wittingham Cancer Center @ Norwalk Hospital
      • Waterbury, Connecticut, United States, 06708
        • Medical Oncology & Hematology, P.C.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, United States, 30322-1013
        • Winship Cancer Institute, Emory University
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute at Emory University
      • Atlanta, Georgia, United States, 30303
        • Winship Cancer Institute at Grady Health Systems
      • Augusta, Georgia, United States, 30901
        • Augusta Oncology Associates, P.C.
      • Augusta, Georgia, United States, 30909
        • Augusta Oncology Associates, PC
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists
      • Gainesville, Georgia, United States, 30501
        • The Longstreet Cancer Center
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care, P.C.
      • Marietta, Georgia, United States, 30106
        • Northwest Georgia Oncology Center
      • Warner Robins, Georgia, United States, 31088-2259
        • Central Georgia Cancer Care, P.C.
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center at Post Falls
    • Illinois
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Blood and Cancer Disorders
      • Rockville, Maryland, United States, 20850
        • Associates in Oncology/Hematology, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Oncology/Hematology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  • progressed after 1-2 prior chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) 0-2;
  • tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

  • prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  • active or untreated Central Nervous System (CNS) metastases;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Erlotinib
Continuous oral dosing at 150 mg daily.
Experimental: B
Drug: PF-00299804
Continuous oral dosing at 45mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame: Baseline up to Cycle 44 (Week 188)
EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.
Baseline up to Cycle 44 (Week 188)
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)
Time Frame: Baseline up to Cycle 44 (Week 188)
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.
Baseline up to Cycle 44 (Week 188)
Dermatology Life Quality Index (DLQI)
Time Frame: Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.
Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
Percentage of Participants With Objective Response
Time Frame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Best Overall Response (BOR)
Time Frame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Duration of Response (DR)
Time Frame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Overall Survival (OS)
Time Frame: Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.
Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation
Time Frame: Baseline
Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as "unknown". Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.
Baseline
Soluble Protein Biomarkers Level
Time Frame: Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)
Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.
Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)
Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)
Time Frame: C1D10-14, C2D1, C3D1, C4D1
Only participants from "Dacomitinib" treatment arm were planned to be analyzed for this outcome.
C1D10-14, C2D1, C3D1, C4D1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7471028
  • 2008-005235-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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