Non-small Cell Lung Cancer Clinical Trial
Official title:
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
Verified date | September 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 188 |
Est. completion date | August 2014 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
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; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Chris O'Brien Lifehouse | Camperdown | New South Wales |
Australia | St. Vincent's Hospital | Fitzroy | Victoria |
Australia | The Andrew Love Cancer Centre, | Geelong | Victoria |
Australia | Border Medical Oncology | Wodonga | Victoria |
Brazil | FUNDACAO PIO XII Hospital de Cancer de Barretos | Barretos | SP |
Brazil | Hospital Sao Lucas da PUCRS | Porto Alegre | RS |
Brazil | Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita | Porto Alegre | RS |
Brazil | Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP | Sao Paulo | SP |
Canada | Royal Victoria Hospital | Barrie | Ontario |
Canada | RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa | Oshawa | Ontario |
Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
Canada | BC Cancer Agency - Vancouver Centre | Vancouver | British Columbia |
Hong Kong | Department of Clinical Oncology | Shatin | New Territories |
Hong Kong | Department of Clinical Oncology, Tuen Mun Hospital | Tuen Mun | New Territories |
Korea, Republic of | SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center | Seoul | |
Poland | Medex spolka cywilna | Chrzanow | |
Poland | "Vesalius" Sp. z o.o. | Krakow | |
Poland | ¿KardioDent¿ | Krakow | |
Poland | Zaklad Rentgena i USG Wyrobek spolka jawna | Krakow | |
Poland | Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie | Warsaw | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne | Warszawa | |
Puerto Rico | Ponce School of Medicine / CAIMED Center | Ponce | |
Singapore | National Cancer Centre | Singapore | |
Spain | Hospital Universitari Germans Trias I Pujol | Badalona | Barcelona |
Spain | Hospital de Cruces | Barakaldo | Vizcaya |
Spain | Hospital Teresa Herrera | La Coruña | |
Spain | Hospital Son Llatzer | Palma de Mallorca | Islas Baleares |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital, Chest Department | Taipei | |
United Kingdom | Christie Hospital NHS Foundation Trust | Manchester | |
United Kingdom | Churchill Hospital | Oxford | |
United States | Winship Cancer Institute at Emory University | Atlanta | Georgia |
United States | Winship Cancer Institute at Grady Health Systems | Atlanta | Georgia |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
United States | Augusta Oncology Associates, P.C. | Augusta | Georgia |
United States | Augusta Oncology Associates, PC | Augusta | Georgia |
United States | Center for Blood and Cancer Disorders | Bethesda | Maryland |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Oncology/Hematology Associates | Clarksburg | West Virginia |
United States | John B. Amos Cancer Center | Columbus | Georgia |
United States | Georgia Cancer Specialists | Decatur | Georgia |
United States | The Longstreet Cancer Center | Gainesville | Georgia |
United States | Central Georgia Cancer Care, P.C. | Macon | Georgia |
United States | Northwest Georgia Oncology Center | Marietta | Georgia |
United States | The West Clinic | Memphis | Tennessee |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Agajanian Institute of Oncology and Hematology | Montebello | California |
United States | Northwest Alabama Cancer Center | Muscle Shoals | Alabama |
United States | Wittingham Cancer Center @ Norwalk Hospital | Norwalk | Connecticut |
United States | Kootenai Cancer Center | Post Falls | Idaho |
United States | Kootenai Cancer Center at Post Falls | Post Falls | Idaho |
United States | Associates in Oncology/Hematology, PC | Rockville | Maryland |
United States | Central Georgia Cancer Care, P.C. | Warner Robins | Georgia |
United States | Medical Oncology & Hematology, P.C. | Waterbury | Connecticut |
United States | Midwestern Regional Medical Center | Zion | Illinois |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Brazil, Canada, Hong Kong, Korea, Republic of, Poland, Puerto Rico, Singapore, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation | 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 | No |
Other | Soluble Protein Biomarkers Level | 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) | No |
Other | Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804) | Only participants from "Dacomitinib" treatment arm were planned to be analyzed for this outcome. | C1D10-14, C2D1, C3D1, C4D1 | No |
Primary | Progression-Free Survival (PFS) | 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 | No |
Secondary | 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) | 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) | No |
Secondary | 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) | 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) | No |
Secondary | Dermatology Life Quality Index (DLQI) | 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 | No |
Secondary | Percentage of Participants With Objective Response | 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 | No |
Secondary | Best Overall Response (BOR) | 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 | No |
Secondary | Duration of Response (DR) | 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 | No |
Secondary | Overall Survival (OS) | 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. | No |
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