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Trial registered on ANZCTR


Registration number
ACTRN12610000312044
Ethics application status
Approved
Date submitted
9/04/2010
Date registered
19/04/2010
Date last updated
29/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A Double Blind Placebo Controlled Randomised Trial of PF-804 in Patients with Incurable Stage IIIB / IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease
Scientific title
A double blind placebo controlled randomized trial to evaluate the effect of PF-804 on overall survival in patients with incurable stage IIIb/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease
Secondary ID [1] 1609 0
NCT01000025 ClinicalTrials.gov
Universal Trial Number (UTN)
U1111-1112-9254
Trial acronym
BR.26
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 257118 0
Condition category
Condition code
Cancer 257271 257271 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PF-804 administered orally once daily at a daily dose of 45mg (in 28 day cycles) until disease progression or unacceptable toxicity
Intervention code [1] 255706 0
Treatment: Drugs
Comparator / control treatment
Placebo (microcellulose pill) administered orally once daily at a daily dose of 45mg until disease progression or unacceptable toxicity
Control group
Placebo

Outcomes
Primary outcome [1] 258190 0
To compare overall survival between the two arms. Patients are assessed for survival with a clinical examination monthly during treatment,4 weeks after the end of treatment, and then every 4 weeks after completion of treatment.
Timepoint [1] 258190 0
After 640 deaths have occurred on study
Secondary outcome [1] 263829 0
To compare progression-free survival between the two arms using Computerised Tomography (CT) scans
Timepoint [1] 263829 0
At the end of cycle 1, end of cycle 2, the end of every 2nd cycle of treatment (eg cycle 2, 4, 6 until protocol therapy has ceased, then every 12 weeks after protocol therapy has ceased until disease progression occurs
Secondary outcome [2] 263831 0
To compare objective response rates between the two arms using CT scans
Timepoint [2] 263831 0
At the end of cycle 1, end of cycle 2, the end of every 2nd cycle of treatment (eg cycle 2, 4, 6 until protocol therapy has ceased, then every 12 weeks after protocol therapy has ceased until disease progression occurs
Secondary outcome [3] 263832 0
To estimate time to response and response duration using CT scans
Timepoint [3] 263832 0
At the end of cycle 1, end of cycle 2, the end of every 2nd cycle of treatment (eg cycle 2, 4, 6 until protocol therapy has ceased, then every 12 weeks after protocol therapy has ceased until disease progression occurs
Secondary outcome [4] 263833 0
To evaluate the nature,severity and frequency of toxicities between the two arms using patient reporting of adverse events and blood analysis
Timepoint [4] 263833 0
Continuously throughout the study - assessed on day 1 of each cycle (4 weeks) until the end of protocol therapy, 4 weeks after the end of protocol therapy and then every 12 weeks until patient death
Secondary outcome [5] 263834 0
To compare quality of life between the two arms using a validated quality of life questionnaire (QLQ-C30)
Timepoint [5] 263834 0
At baseline, at the start of each treatment cycle, 4 weeks after completion of study treatment, and every 12 weeks after completion of study treatment until patient death

Eligibility
Key inclusion criteria
Histologically confirmed diagnosis of non-small cell carcinoma of the lung.
Patients must have evidence of disease, but measurable disease is not mandatory
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
Adequate renal and hepatic functions
Patients must have recovered from any toxic effects and at least 21 days must have elapsed from the
last dose and prior to randomization
Patients < 70 years Must have received 1-2 prior chemotherapy regimens
Patients > 70 years May have received 1 or 2 prior single agent chemotherapy regimens for their disease,
Adjuvant Chemotherapy: Patients may ALSO have had prior adjuvant therapy for completely
resected disease, providing completed at least 12 months prior to randomization.
Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy: Patients may only be enrolled after failure of prior gefitinib or erlotinib for advanced or metastatic disease
Radiation: Patients may have had prior radiation therapy provided that a minimum of 14 days has elapsed between the end of radiotherapy and randomization onto the study
Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed
Patient able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires.
Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements
Patients must be accessible for treatment and follow-up.
protocol treatment is to begin within 2 working days of patient randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
Patients who have experienced untreated and/or uncontrolled cardiovascular conditions Patients with a significant cardiac history, even if controlled, should have a left ventricular ejection fraction (LVEF) > 50%.
Patients with untreated brain or meningeal metastases are not eligible (Computerised Tomography (CT) scans are not required to rule this out unless there is a clinical suspicion of Central Nervous System (CNS) disease).
Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which
would not permit the patient to be managed according to the protocol
Mean QTc (a measure of the time between the start of the Q wave and the end of the T wave) with Bazetts correction > 470msec in screening electrocardiogram (ECG) or history of familial long QT syndrome.
Drugs that are highly dependent on Cytochrome P450 2D6 (CYP2D6) for metabolism are prohibited
Pregnancy or inadequate contraception

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)
Central blinded randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA
Recruitment postcode(s) [1] 2749 0
2050
Recruitment postcode(s) [2] 2750 0
3144
Recruitment postcode(s) [3] 2751 0
2310
Recruitment postcode(s) [4] 2752 0
2170
Recruitment postcode(s) [5] 2753 0
3168
Recruitment postcode(s) [6] 2754 0
4560
Recruitment postcode(s) [7] 2755 0
3199
Recruitment postcode(s) [8] 2756 0
3002
Recruitment postcode(s) [9] 2757 0
4032
Recruitment postcode(s) [10] 2758 0
2031
Recruitment postcode(s) [11] 2759 0
5000
Recruitment postcode(s) [12] 2760 0
6009

Funding & Sponsors
Funding source category [1] 256785 0
Other Collaborative groups
Name [1] 256785 0
NCIC Clinical Trials Group
Country [1] 256785 0
Canada
Primary sponsor type
Other Collaborative groups
Name
NCIC Clinical Trials Group
Address
Cancer Clinical Trials Division
Cancer Research Institute
Queen's University
10 Stuart Street
Kingston, Ontario K7L 3N6
Country
Canada
Secondary sponsor category [1] 256061 0
University
Name [1] 256061 0
University of Sydney
Address [1] 256061 0
National Health & Medical Research Council Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [1] 256061 0
Australia
Other collaborator category [1] 1198 0
Other Collaborative groups
Name [1] 1198 0
Australiasian Lung Cancer Trials Group
Address [1] 1198 0
ALTG Group Manager
The Australian Lung Foundation
PO Box 847
Lutwyche, QLD 4030
Country [1] 1198 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258809 0
NSW Cancer Institute Clinical Research Ethics Committee
Ethics committee address [1] 258809 0
PO Box 41
Alexandria, NSW 1435
Ethics committee country [1] 258809 0
Australia
Date submitted for ethics approval [1] 258809 0
31/08/2009
Approval date [1] 258809 0
02/12/2009
Ethics approval number [1] 258809 0
HREC/09/CIC/28

Summary
Brief summary
This study looks at the effectiveness of treatment with the drug PF-804 in patients with incurable non-small cell lung cancer, where standard therapy for advanced or widespread disease has not been successful.

Who is it for?
You can join this study if you have a confirmed diagnosis of non-small cell carcinoma of the lung, described as incurable stage IIIB or IV, where standard therapy has not been successful.

Trial details
Participants will be randomly divided into two groups. One group will receive a non-active (placebo) treatment, and the other will receive treatment with the drug PF-804, both taken orally (in cycles of 28 days)until the disease progresses or toxicity is unacceptable. The aim is to compare the overall survival between the two groups, and to monitor the effects of the treatment. PF-804 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30622 0
Address 30622 0
Country 30622 0
Phone 30622 0
Fax 30622 0
Email 30622 0
Contact person for public queries
Name 13869 0
Eric Tsobanis
Address 13869 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 13869 0
Australia
Phone 13869 0
+61 2 9562 5000
Fax 13869 0
+61 2 9562 5094
Email 13869 0
[email protected]
Contact person for scientific queries
Name 4797 0
Prof Michael Millward
Address 4797 0
Medical Oncology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country 4797 0
Australia
Phone 4797 0
+61 8 9346 2098
Fax 4797 0
+61 8 9346 2816
Email 4797 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.