Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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/show/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) - Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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) - Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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) - Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Timepoint [2] 0 0
Baseline, every 8 weeks until tumor progression or death
Secondary outcome [3] 0 0
Duration of Response (DR) - Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.
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 - EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline 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 - QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
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 - BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
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 - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
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 - EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
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) - Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
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
Gender
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
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
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
The purpose of this study is to determine whether investigational study drug, AG-013736, and
gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
Trial website
https://clinicaltrials.gov/show/NCT00471146
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

Summary results
Other publications