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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00769067
Registration number
NCT00769067
Ethics application status
Date submitted
7/10/2008
Date registered
8/10/2008
Date last updated
7/10/2015
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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2008-005235-14
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Secondary ID [2]
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A7471028
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib
Treatment: Drugs - PF-00299804
Active Comparator: A -
Experimental: B -
Treatment: Drugs: Erlotinib
Continuous oral dosing at 150 mg daily.
Treatment: Drugs: PF-00299804
Continuous oral dosing at 45mg daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Cycle 44 (Week 188)
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Secondary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to Cycle 44 (Week 188)
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Secondary outcome [3]
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Dermatology Life Quality Index (DLQI)
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Assessment method [3]
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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.
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Timepoint [3]
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Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
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Secondary outcome [4]
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Percentage of Participants With Objective Response
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Assessment method [4]
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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.
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Timepoint [4]
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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
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Secondary outcome [5]
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Best Overall Response (BOR)
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Assessment method [5]
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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.
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Timepoint [5]
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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
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Secondary outcome [6]
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Duration of Response (DR)
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Assessment method [6]
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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.
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Timepoint [6]
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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
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
- active or untreated Central Nervous System (CNS) metastases;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2014
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Sample size
Target
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Accrual to date
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Final
188
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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St. Vincent's Hospital - Fitzroy
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Recruitment hospital [3]
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The Andrew Love Cancer Centre, - Geelong
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Recruitment hospital [4]
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Border Medical Oncology - Wodonga
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3690 - Wodonga
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Idaho
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Country [6]
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United States of America
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State/province [6]
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Illinois
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Country [7]
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United States of America
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State/province [7]
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Maryland
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Country [8]
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United States of America
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State/province [8]
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Minnesota
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Country [9]
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United States of America
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State/province [9]
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Tennessee
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Country [10]
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United States of America
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State/province [10]
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West Virginia
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Country [11]
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Brazil
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State/province [11]
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RS
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Country [12]
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Brazil
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State/province [12]
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SP
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Country [13]
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Canada
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State/province [13]
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British Columbia
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Country [14]
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Canada
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State/province [14]
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Ontario
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Country [15]
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Hong Kong
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State/province [15]
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New Territories
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Country [16]
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Korea, Republic of
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State/province [16]
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Seoul
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Poland
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Chrzanow
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Poland
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State/province [18]
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Krakow
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Poland
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Warsaw
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Poland
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Warszawa
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Puerto Rico
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State/province [21]
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Ponce
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Singapore
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State/province [22]
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Singapore
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Spain
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State/province [23]
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Barcelona
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Country [24]
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Spain
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State/province [24]
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Islas Baleares
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Spain
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Vizcaya
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Spain
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State/province [26]
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La Coruña
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Country [27]
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Taiwan
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State/province [27]
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Taipei
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Country [28]
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United Kingdom
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State/province [28]
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Manchester
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Country [29]
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00769067
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00769067
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