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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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)
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
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United States of America
State/province [1] 0 0
California
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Birmingham
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00471146