Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00471146




Registration number
NCT00471146
Ethics application status
Date submitted
7/05/2007
Date registered
9/05/2007
Date last updated
16/07/2012

Titles & IDs
Public title
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Scientific title
A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
Secondary ID [1] 0 0
A4061028
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AG-013736
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - placebo

Experimental: A -

Active comparator: B -


Treatment: Drugs: AG-013736
oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.

Treatment: Drugs: Gemcitabine
intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.

Treatment: Drugs: Gemcitabine
intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline until death or at least 1 year after the randomization of last participant
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline until disease progression or at least 1 year after the randomization of last participant
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [2] 0 0
Baseline, every 8 weeks until tumor progression or death
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
Baseline until death or at least 1 year after the randomization of last participant
Secondary outcome [4] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Timepoint [4] 0 0
Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Secondary outcome [5] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Timepoint [5] 0 0
Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Secondary outcome [6] 0 0
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
Timepoint [6] 0 0
Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Secondary outcome [7] 0 0
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile
Timepoint [7] 0 0
Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Secondary outcome [8] 0 0
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score
Timepoint [8] 0 0
Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Secondary outcome [9] 0 0
Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)
Timepoint [9] 0 0
Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
* Adequate renal, hepatic and bone marrow function.
* Performance status 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with any systemic chemotherapy for metastatic disease.
* Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
* Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
* Inability to take oral medication.

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 3
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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
630
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [4] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Ciudad Autonoma de Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Santa Fe
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Austria
State/province [29] 0 0
Wels
Country [30] 0 0
Austria
State/province [30] 0 0
Wien
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussel
Country [32] 0 0
Belgium
State/province [32] 0 0
Bruxelles
Country [33] 0 0
Belgium
State/province [33] 0 0
Gent
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Wilrijk
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
New Brunswick
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
France
State/province [42] 0 0
Clichy cedex
Country [43] 0 0
France
State/province [43] 0 0
La Chaussee Saint Victor
Country [44] 0 0
France
State/province [44] 0 0
Marseille
Country [45] 0 0
France
State/province [45] 0 0
Montpellier Cedex 02
Country [46] 0 0
France
State/province [46] 0 0
PARIS Cedex 13
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Pessac Cedex
Country [49] 0 0
France
State/province [49] 0 0
Rouen
Country [50] 0 0
France
State/province [50] 0 0
St Herblain Cedex
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
Country [52] 0 0
Germany
State/province [52] 0 0
Dresden
Country [53] 0 0
Germany
State/province [53] 0 0
Essen
Country [54] 0 0
Germany
State/province [54] 0 0
Greifswald
Country [55] 0 0
Germany
State/province [55] 0 0
Magdeburg
Country [56] 0 0
Germany
State/province [56] 0 0
Mannheim
Country [57] 0 0
Germany
State/province [57] 0 0
Muenchen
Country [58] 0 0
Germany
State/province [58] 0 0
Oldenburg
Country [59] 0 0
Germany
State/province [59] 0 0
Ulm
Country [60] 0 0
Hong Kong
State/province [60] 0 0
NT
Country [61] 0 0
Hungary
State/province [61] 0 0
Budapest
Country [62] 0 0
Hungary
State/province [62] 0 0
Kaposvar
Country [63] 0 0
Hungary
State/province [63] 0 0
Szentes
Country [64] 0 0
Hungary
State/province [64] 0 0
Zalaegerszeg
Country [65] 0 0
India
State/province [65] 0 0
Gujarat
Country [66] 0 0
India
State/province [66] 0 0
Karnataka
Country [67] 0 0
India
State/province [67] 0 0
Kerala
Country [68] 0 0
India
State/province [68] 0 0
Pradesh
Country [69] 0 0
India
State/province [69] 0 0
Tamil Nadu
Country [70] 0 0
Ireland
State/province [70] 0 0
Dublin 24
Country [71] 0 0
Ireland
State/province [71] 0 0
Dublin
Country [72] 0 0
Italy
State/province [72] 0 0
Bologna
Country [73] 0 0
Italy
State/province [73] 0 0
Catania
Country [74] 0 0
Italy
State/province [74] 0 0
Milano
Country [75] 0 0
Italy
State/province [75] 0 0
Padova
Country [76] 0 0
Italy
State/province [76] 0 0
Verona
Country [77] 0 0
Japan
State/province [77] 0 0
Aichi
Country [78] 0 0
Japan
State/province [78] 0 0
Chiba-ken
Country [79] 0 0
Japan
State/province [79] 0 0
Chiba
Country [80] 0 0
Japan
State/province [80] 0 0
Fukuoka-ken
Country [81] 0 0
Japan
State/province [81] 0 0
Kanagawa
Country [82] 0 0
Japan
State/province [82] 0 0
Osaka-fu
Country [83] 0 0
Japan
State/province [83] 0 0
Shizuoka
Country [84] 0 0
Japan
State/province [84] 0 0
Tokyo
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Seoul
Country [86] 0 0
Netherlands
State/province [86] 0 0
Noord Holland
Country [87] 0 0
Netherlands
State/province [87] 0 0
Amsterdam
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Moscow
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Omsk
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Sochi
Country [91] 0 0
Russian Federation
State/province [91] 0 0
St. Petersburg
Country [92] 0 0
Singapore
State/province [92] 0 0
Singapore
Country [93] 0 0
South Africa
State/province [93] 0 0
Cape Town
Country [94] 0 0
South Africa
State/province [94] 0 0
Observatory
Country [95] 0 0
South Africa
State/province [95] 0 0
Parktown
Country [96] 0 0
South Africa
State/province [96] 0 0
Port Elizabeth
Country [97] 0 0
South Africa
State/province [97] 0 0
Pretoria
Country [98] 0 0
South Africa
State/province [98] 0 0
Sandton
Country [99] 0 0
Spain
State/province [99] 0 0
Islas Baleares
Country [100] 0 0
Spain
State/province [100] 0 0
Madrid
Country [101] 0 0
Spain
State/province [101] 0 0
Navarra
Country [102] 0 0
Spain
State/province [102] 0 0
Barcelona
Country [103] 0 0
Spain
State/province [103] 0 0
Las Palmas de Gran Canaria
Country [104] 0 0
Spain
State/province [104] 0 0
Malaga
Country [105] 0 0
Spain
State/province [105] 0 0
Santa Cruz de Tenerife
Country [106] 0 0
Spain
State/province [106] 0 0
Toledo
Country [107] 0 0
Sweden
State/province [107] 0 0
Lund
Country [108] 0 0
Sweden
State/province [108] 0 0
Uppsala
Country [109] 0 0
Switzerland
State/province [109] 0 0
Winterthur
Country [110] 0 0
Taiwan
State/province [110] 0 0
Taoyuan County
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taichung
Country [112] 0 0
Taiwan
State/province [112] 0 0
Taipei
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Cardiff
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Kent
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Leicestershire
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Manchester
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Middlesex
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Birmingham
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Edinburgh
Country [120] 0 0
United Kingdom
State/province [120] 0 0
London
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Southhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

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/NCT00471146