Trial · NCT00471146
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
NCT00471146, Phase 3, Completed, Pfizer; results first posted 2012-07-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer. Trials, record NCT00471146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471146
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
- NCT number
- NCT00471146
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 630 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Pancreatic Ductal
- Interventions
- AG-013736, Gemcitabine, Gemcitabine, placebo
- First posted
- 2007-05-09
- Last updated
- 2012-07-16
- Results first posted
- 2012-07-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Baseline until death or at least 1 year after the randomization of last participant | 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). |
| Secondary | Progression Free Survival (PFS) | Baseline until disease progression or at least 1 year after the randomization of last participant | 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"). |
| Secondary | Percentage of Participants With Objective Response (OR) | Baseline, every 8 weeks until tumor progression or death | 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. |
| Secondary | Duration of Response (DR) | Baseline until death or at least 1 year after the randomization of last participant | 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. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | 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. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | 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. |
| Secondary | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | 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. |
| Secondary | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | 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. |
| Secondary | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | 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. |
| Secondary | Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) | Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline until death or at least 1 year after the randomization of last participant | Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Weeks | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Baseline until disease progression or at least 1 year after the randomization of last participant | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Baseline, every 8 weeks until tumor progression or death | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Baseline until death or at least 1 year after the randomization of last participant | DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR). | Weeks | MEDIAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Millimeter (mm) | MEAN |
| SECONDARY | Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) | Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group1,268
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Axitinib + Gemcitabine | 36.9 | 95% Confidence Interval 30.1 to 41.1 | Weeks | |
| Overall Survival (OS) | Placebo + Gemcitabine | 35.8 | 95% Confidence Interval 30.0 to 44.8 | Weeks | |
| Progression Free Survival (PFS) | Axitinib + Gemcitabine | 19.1 | 95% Confidence Interval 17.1 to 24.4 | Weeks | |
| Progression Free Survival (PFS) | Placebo + Gemcitabine | 18.9 | 95% Confidence Interval 16.2 to 22.6 | Weeks | |
| Percentage of Participants With Objective Response (OR) | Axitinib + Gemcitabine | 4.9 | 95% Confidence Interval 2.5 to 8.3 | Percentage of participants | |
| Percentage of Participants With Objective Response (OR) | Placebo + Gemcitabine | 1.6 | 95% Confidence Interval 0.4 to 4.0 | Percentage of participants | |
| Duration of Response (DR) | Axitinib + Gemcitabine | 33.1 | 95% Confidence Interval 16.1 to 33.1 | Weeks | |
| Duration of Response (DR) | Placebo + Gemcitabine | NA | 95% Confidence Interval NA to NA | Weeks | |
| Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Axitinib + Gemcitabine | Physical functioning: Baseline (n=295, 289) | 77.445 | Standard Deviation 20.3052 | Units on a scale |
| Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Placebo + Gemcitabine | Physical functioning: Baseline (n=295, 289) | 78.546 | Standard Deviation 18.9192 | Units on a scale |
1 to 10 of 1,268Source ClinicalTrials.gov
See all 1,268 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Axitinib + Gemcitabine | 314 | |
| Overall Study | STARTED | Placebo + Gemcitabine | 316 | |
| Overall Study | Treated | Axitinib + Gemcitabine | 305 | |
| Overall Study | Treated | Placebo + Gemcitabine | 308 | |
| Overall Study | COMPLETED | Axitinib + Gemcitabine | 142 | |
| Overall Study | COMPLETED | Placebo + Gemcitabine | 142 | |
| Overall Study | NOT COMPLETED | Axitinib + Gemcitabine | 172 | |
| Overall Study | NOT COMPLETED | Placebo + Gemcitabine | 174 |
Source ClinicalTrials.gov
Adverse events1,434
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Axitinib + Gemcitabine | 25 | 304 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Gemcitabine | 51 | 309 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Axitinib + Gemcitabine | 1 | 304 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Placebo + Gemcitabine | 0 | 309 | |
| other | Eosinopenia | Blood and lymphatic system disorders | Axitinib + Gemcitabine | 1 | 304 | |
| other | Eosinopenia | Blood and lymphatic system disorders | Placebo + Gemcitabine | 0 | 309 | |
| other | Erythroblastosis | Blood and lymphatic system disorders | Axitinib + Gemcitabine | 0 | 304 | |
| other | Erythroblastosis | Blood and lymphatic system disorders | Placebo + Gemcitabine | 1 | 309 | |
| other | Erythropenia | Blood and lymphatic system disorders | Axitinib + Gemcitabine | 0 | 304 | |
| other | Erythropenia | Blood and lymphatic system disorders | Placebo + Gemcitabine | 1 | 309 |
1 to 10 of 1,434Source ClinicalTrials.gov
See all 1,434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Axitinib + Gemcitabine | ||
| Total, all-cause mortality | Placebo + Gemcitabine | ||
| Total, other adverse events | Axitinib + Gemcitabine | 276 | 304 |
| Total, other adverse events | Placebo + Gemcitabine | 276 | 309 |
| Total, serious adverse events | Axitinib + Gemcitabine | 108 | 304 |
| Total, serious adverse events | Placebo + Gemcitabine | 102 | 309 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21306953 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Axitinib + Gemcitabine vs Placebo + Gemcitabine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00471146
GET https://conductscience.org/api/trials/v1/NCT00471146/results?page=2