Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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
Query!
Secondary ID [1]
0
0
2008-005235-14
Query!
Secondary ID [2]
0
0
A7471028
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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
Query!
Secondary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline up to Cycle 44 (Week 188)
Query!
Secondary outcome [2]
0
0
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)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to Cycle 44 (Week 188)
Query!
Secondary outcome [3]
0
0
Dermatology Life Quality Index (DLQI)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Objective Response
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
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
Query!
Secondary outcome [5]
0
0
Best Overall Response (BOR)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
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
Query!
Secondary outcome [6]
0
0
Duration of Response (DR)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
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
Query!
Secondary outcome [7]
0
0
Overall Survival (OS)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
* active or untreated Central Nervous System (CNS) metastases;
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
188
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Chris O'Brien Lifehouse - Camperdown
Query!
Recruitment hospital [2]
0
0
St. Vincent's Hospital - Fitzroy
Query!
Recruitment hospital [3]
0
0
The Andrew Love Cancer Centre, - Geelong
Query!
Recruitment hospital [4]
0
0
Border Medical Oncology - Wodonga
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [4]
0
0
3690 - Wodonga
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
West Virginia
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
RS
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
SP
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
British Columbia
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Ontario
Query!
Country [15]
0
0
Hong Kong
Query!
State/province [15]
0
0
New Territories
Query!
Country [16]
0
0
Korea, Republic of
Query!
State/province [16]
0
0
Seoul
Query!
Country [17]
0
0
Poland
Query!
State/province [17]
0
0
Chrzanow
Query!
Country [18]
0
0
Poland
Query!
State/province [18]
0
0
Krakow
Query!
Country [19]
0
0
Poland
Query!
State/province [19]
0
0
Warsaw
Query!
Country [20]
0
0
Poland
Query!
State/province [20]
0
0
Warszawa
Query!
Country [21]
0
0
Puerto Rico
Query!
State/province [21]
0
0
Ponce
Query!
Country [22]
0
0
Singapore
Query!
State/province [22]
0
0
Singapore
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Barcelona
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Islas Baleares
Query!
Country [25]
0
0
Spain
Query!
State/province [25]
0
0
Vizcaya
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
La Coruña
Query!
Country [27]
0
0
Taiwan
Query!
State/province [27]
0
0
Taipei
Query!
Country [28]
0
0
United Kingdom
Query!
State/province [28]
0
0
Manchester
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00769067
Query!
Trial related presentations / publications
Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum In: Ann Oncol. 2016 Jul;27(7):1363. doi: 10.1093/annonc/mdw221.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00769067
Download to PDF