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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00674973




Registration number
NCT00674973
Ethics application status
Date submitted
30/04/2008
Date registered
8/05/2008
Date last updated
17/06/2016

Titles & IDs
Public title
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Scientific title
A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
Secondary ID [1] 0 0
2007-003738-40
Secondary ID [2] 0 0
BO21129
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib
Treatment: Drugs - Placebo

Experimental: Erlotinib - Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.

Placebo Comparator: Placebo - Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.


Treatment: Drugs: Erlotinib
Participants received erlotinib 150 mg tablet orally once daily.

Treatment: Drugs: Placebo
Participants received placebo matching to erlotinib 150 mg tablet orally once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival - Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.
Timepoint [1] 0 0
From the time of randomization until progression of disease or death (up to 30 months)
Secondary outcome [1] 0 0
Percentage of Participants With Best Overall Response Rate - Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Timepoint [1] 0 0
From the time of randomization until progression of disease or death (up to 30 months)
Secondary outcome [2] 0 0
Percentage of Participants With Disease Control Rate (DCR) - Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Timepoint [2] 0 0
Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
Secondary outcome [3] 0 0
Overall Survival - Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.
Timepoint [3] 0 0
From the time of randomization until or death (up to 30 months)
Secondary outcome [4] 0 0
Number of Participants With Adverse Events (AEs) - An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Timepoint [4] 0 0
Up to 28 days after discontinuation of study drug (up to 30 months)

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- histologically or cytologically documented locally advanced-unresectable or metastatic
pancreatic cancer;

- measurable disease according to RECIST;

- failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for
chemotherapy;

- ECOG performance status of 0-2.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- local or locally advanced-resectable pancreatic cancer;

- any other malignancies within last 5 years, except for adequately treated cancer in
situ of the cervix, or basal or squamous cell skin cancer;

- major surgery within 2 weeks prior to randomization.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Box Hill
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2076 - Sydney
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
BA
Country [2] 0 0
Brazil
State/province [2] 0 0
MG
Country [3] 0 0
Brazil
State/province [3] 0 0
PR
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Gabrovo
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Pleven
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Plovdiv
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Vratsa
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Vratza
Country [12] 0 0
Croatia
State/province [12] 0 0
Zagreb
Country [13] 0 0
Germany
State/province [13] 0 0
Bochum
Country [14] 0 0
Germany
State/province [14] 0 0
Dresden
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Germany
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Esslingen
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Germany
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Greifswald
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Germany
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Hamburg
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Germany
State/province [18] 0 0
Köln
Country [19] 0 0
Germany
State/province [19] 0 0
Saarbruecken
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Germany
State/province [20] 0 0
Ulm
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Hong Kong
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India
State/province [22] 0 0
Bangalore
Country [23] 0 0
India
State/province [23] 0 0
Chennai
Country [24] 0 0
India
State/province [24] 0 0
Jaipur
Country [25] 0 0
India
State/province [25] 0 0
Kochi
Country [26] 0 0
India
State/province [26] 0 0
Kolkata
Country [27] 0 0
India
State/province [27] 0 0
Ludhiana
Country [28] 0 0
India
State/province [28] 0 0
Mumbai
Country [29] 0 0
India
State/province [29] 0 0
New Delhi
Country [30] 0 0
India
State/province [30] 0 0
Pune
Country [31] 0 0
India
State/province [31] 0 0
Vellore
Country [32] 0 0
Italy
State/province [32] 0 0
Emilia-Romagna
Country [33] 0 0
Italy
State/province [33] 0 0
Friuli-Venezia Giulia
Country [34] 0 0
Latvia
State/province [34] 0 0
Riga
Country [35] 0 0
Lithuania
State/province [35] 0 0
Kaunas
Country [36] 0 0
Lithuania
State/province [36] 0 0
Vilnius
Country [37] 0 0
Malaysia
State/province [37] 0 0
Kuala Lumpur
Country [38] 0 0
Malaysia
State/province [38] 0 0
Penang
Country [39] 0 0
Mexico
State/province [39] 0 0
Monterrey
Country [40] 0 0
Peru
State/province [40] 0 0
Arequipa
Country [41] 0 0
Peru
State/province [41] 0 0
Chiclayo
Country [42] 0 0
Peru
State/province [42] 0 0
San Isidro
Country [43] 0 0
Romania
State/province [43] 0 0
Bucharest
Country [44] 0 0
Romania
State/province [44] 0 0
Cluj Napoca
Country [45] 0 0
Romania
State/province [45] 0 0
Craiova (Dolj county)
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Irkutsk
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Singapore
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Singapore
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Slovenia
State/province [52] 0 0
Ljubljana
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Ukraine
State/province [53] 0 0
Kiev
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to identify biomarkers which may predict improvement in progression
free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who
failed one prior regimen of standard chemotherapy or who are deemed unsuitable for
chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient
population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po
daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study
treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00674973
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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
Other publications