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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
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
Secondary ID [1] 0 0
2008-005235-14
Secondary ID [2] 0 0
A7471028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
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
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)
Timepoint [1] 0 0
Baseline up to Cycle 44 (Week 188)
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)
Timepoint [2] 0 0
Baseline up to Cycle 44 (Week 188)
Secondary outcome [3] 0 0
Dermatology Life Quality Index (DLQI)
Timepoint [3] 0 0
Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
Secondary outcome [4] 0 0
Percentage of Participants With Objective Response
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
Secondary outcome [5] 0 0
Best Overall Response (BOR)
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
Secondary outcome [6] 0 0
Duration of Response (DR)
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
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.

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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
* active or untreated Central Nervous System (CNS) metastases;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
The Andrew Love Cancer Centre, - Geelong
Recruitment hospital [4] 0 0
Border Medical Oncology - Wodonga
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
Brazil
State/province [11] 0 0
RS
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Hong Kong
State/province [15] 0 0
New Territories
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Poland
State/province [17] 0 0
Chrzanow
Country [18] 0 0
Poland
State/province [18] 0 0
Krakow
Country [19] 0 0
Poland
State/province [19] 0 0
Warsaw
Country [20] 0 0
Poland
State/province [20] 0 0
Warszawa
Country [21] 0 0
Puerto Rico
State/province [21] 0 0
Ponce
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Islas Baleares
Country [25] 0 0
Spain
State/province [25] 0 0
Vizcaya
Country [26] 0 0
Spain
State/province [26] 0 0
La Coruña
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Manchester
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00769067
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00769067