Trial · NCT00920816
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
NCT00920816, Phase 3, Completed, Pfizer; results first posted 2014-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer. Trials, record NCT00920816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00920816
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
- NCT number
- NCT00920816
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 492 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Kidney Neoplasms
- Interventions
- Axitinib (AG-013736), Sorafenib
- First posted
- 2009-06-15
- Last updated
- 2022-05-06
- Other registries' IDs
- eudract:2010-018585-23
- Results first posted
- 2014-02-04
- Limitations and caveats
The objective of the statistical analysis for secondary endpoints was to summarize data using descriptive statistics without performing any hypothesis testing. Safety analysis did not include data from all China participants due to inability to obtain timely approval to use data in accordance to HGRAC regulations.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. |
| Primary | Progression Free Survival (PFS): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. |
| Secondary | Percentage of Participants With Objective Response (OR): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to 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 | Percentage of Participants With Objective Response (OR): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to 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): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Time in months from the first documentation of objective tumor response that is subsequently confirmed 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Secondary | Duration of Response (DR): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Time in months from the first documentation of objective tumor response that is subsequently confirmed 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Secondary | Overall Survival (OS): First-Line Participants | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | Time in months from date of 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 30.4. 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 | Overall Survival (OS): Second-Line Participants | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | Time in months from date of 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 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Other | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
| Other | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | FAS included all treatment-naive 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. | months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | FAS included all previously-treated Asian 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. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | FAS included all treatment-naive 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 | Percentage of Participants With Objective Response (OR): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | FAS included all previously-treated Asian 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): First-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR). | months | MEDIAN |
| SECONDARY | Duration of Response (DR): Second-Line Participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR). | months | MEDIAN |
| SECONDARY | Overall Survival (OS): First-Line Participants | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) | FAS included all treatment-naive 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. | months | MEDIAN |
| SECONDARY | Overall Survival (OS): Second-Line Participants | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) | FAS included all previously-treated Asian 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. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) | FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) | FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | units on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group400
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS): First-Line Participants | Axitinib (First-line Participants) | 10.1 | 95% Confidence Interval 7.2 to 12.1 | months | |
| Progression Free Survival (PFS): First-Line Participants | Sorafenib (First-line Participants) | 6.5 | 95% Confidence Interval 4.7 to 8.3 | months | |
| Progression Free Survival (PFS): Second-Line Participants | Axitinib (Second-line Participants) | 6.5 | 95% Confidence Interval 4.7 to 9.1 | months | |
| Progression Free Survival (PFS): Second-Line Participants | Sorafenib (Second-line Participants) | 4.8 | 95% Confidence Interval 3.0 to 6.5 | months | |
| Percentage of Participants With Objective Response (OR): First-Line Participants | Axitinib (First-line Participants) | 32.3 | 95% Confidence Interval 25.7 to 39.4 | percentage of participants | |
| Percentage of Participants With Objective Response (OR): First-Line Participants | Sorafenib (First-line Participants) | 14.6 | 95% Confidence Interval 8.2 to 23.3 | percentage of participants | |
| Percentage of Participants With Objective Response (OR): Second-Line Participants | Axitinib (Second-line Participants) | 23.7 | 95% Confidence Interval 16.8 to 31.8 | percentage of participants | |
| Percentage of Participants With Objective Response (OR): Second-Line Participants | Sorafenib (Second-line Participants) | 10.1 | 95% Confidence Interval 4.2 to 19.8 | percentage of participants | |
| Duration of Response (DR): First-Line Participants | Axitinib (First-line Participants) | 14.7 | 95% Confidence Interval 11.0 to NA | months | |
| Duration of Response (DR): First-Line Participants | Sorafenib (First-line Participants) | 14.3 | 95% Confidence Interval 11.3 to NA | months |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Axitinib (First-line Participants) | 192 | |
| Overall Study | STARTED | Sorafenib (First-line Participants) | 96 | |
| Overall Study | STARTED | Axitinib (Second-line Participants) | 135 | |
| Overall Study | STARTED | Sorafenib (Second-line Participants) | 69 | |
| Overall Study | Treated | Axitinib (First-line Participants) | 189 | |
| Overall Study | Treated | Sorafenib (First-line Participants) | 96 | |
| Overall Study | Treated | Axitinib (Second-line Participants) | 135 | |
| Overall Study | Treated | Sorafenib (Second-line Participants) | 69 | |
| Overall Study | Participants From China (Excluded From Safety Analysis) | Axitinib (First-line Participants) | 16 | |
| Overall Study | Participants From China (Excluded From Safety Analysis) | Sorafenib (First-line Participants) | 8 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,020
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 | Hypothyroidism | Endocrine disorders | Axitinib (First-line Participants) | 36 | 173 | |
| other | Hypothyroidism | Endocrine disorders | Sorafenib (First-line Participants) | 5 | 88 | |
| other | Hypothyroidism | Endocrine disorders | Axitinib (Second-line Participants) | 3 | 11 | |
| other | Hypothyroidism | Endocrine disorders | Sorafenib (Second-line Participants) | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Axitinib (First-line Participants) | 17 | 173 | |
| other | Abdominal pain | Gastrointestinal disorders | Sorafenib (First-line Participants) | 8 | 88 | |
| other | Abdominal pain | Gastrointestinal disorders | Axitinib (Second-line Participants) | 3 | 11 | |
| other | Abdominal pain | Gastrointestinal disorders | Sorafenib (Second-line Participants) | 0 | 5 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Axitinib (First-line Participants) | 32 | 173 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sorafenib (First-line Participants) | 7 | 88 |
1 to 10 of 1,020Source ClinicalTrials.gov
See all 1,020 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Axitinib (First-line Participants) | 117 | 173 |
| Total, all-cause mortality | Sorafenib (First-line Participants) | 63 | 88 |
| Total, all-cause mortality | Axitinib (Second-line Participants) | 9 | 11 |
| Total, all-cause mortality | Sorafenib (Second-line Participants) | 3 | 5 |
| Total, other adverse events | Axitinib (First-line Participants) | 161 | 173 |
| Total, other adverse events | Sorafenib (First-line Participants) | 83 | 88 |
| Total, other adverse events | Axitinib (Second-line Participants) | 11 | 11 |
| Total, other adverse events | Sorafenib (Second-line Participants) | 5 | 5 |
| Total, serious adverse events | Axitinib (First-line Participants) | 77 | 173 |
| Total, serious adverse events | Sorafenib (First-line Participants) | 26 | 88 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00920816
GET https://conductscience.org/api/trials/v1/NCT00920816/results?page=2