Trial · NCT00678392
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
NCT00678392, Phase 3, Completed, Pfizer; results first posted 2012-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer. Trials, record NCT00678392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00678392
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
- NCT number
- NCT00678392
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 723 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Kidney Neoplasms
- Interventions
- Axitinib (AG-013736), Sorafenib
- First posted
- 2008-05-15
- Last updated
- 2019-01-09
- Other registries' IDs
- eudract:2008-001451-21
- Results first posted
- 2012-03-27
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From initiation of treatment up to follow-up period (up to 3 years) | PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray. |
| Secondary | Overall Survival (OS) | From initiation of treatment up to follow-up period (up to 3 years) | OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive. |
| Secondary | Objective Response Rate (ORR) | From initiation of treatment up to follow-up period (up to 3 years) | ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: \>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. |
| Secondary | Duration of Response (DR) | From initiation of treatment up to follow-up period (up to 3 years) | DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: \>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray. |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From initiation of treatment up to follow-up period (up to 3 years) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs. |
| Secondary | Percentage of Participants With Adverse Events (AEs) by Severity | From initiation of treatment up to follow-up period (up to 3 years) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. |
| Secondary | Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | From initiation of treatment up to follow-up period (up to 3 years) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology | From initiation of treatment up to follow-up period (up to 3 years) | Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry | From initiation of treatment up to follow-up period (up to 3 years) | Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis | From initiation of treatment up to follow-up period (up to 3 years) | Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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) | From initiation of treatment up to follow-up period (up to 3 years) | FAS 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From initiation of treatment up to follow-up period (up to 3 years) | FAS 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. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From initiation of treatment up to follow-up period (up to 3 years) | FAS 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) | From initiation of treatment up to follow-up period (up to 3 years) | FAS 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. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From initiation of treatment up to follow-up period (up to 3 years) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) by Severity | From initiation of treatment up to follow-up period (up to 3 years) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | From initiation of treatment up to follow-up period (up to 3 years) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology | From initiation of treatment up to follow-up period (up to 3 years) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry | From initiation of treatment up to follow-up period (up to 3 years) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis | From initiation of treatment up to follow-up period (up to 3 years) | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group418
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) | Axitinib 5 mg | 6.7 | 95% Confidence Interval 6.3 to 8.6 | Months | |
| Progression-Free Survival (PFS) | Sorafenib 400 mg | 4.7 | 95% Confidence Interval 4.6 to 5.6 | Months | |
| Overall Survival (OS) | Axitinib 5 mg | 20.1 | 95% Confidence Interval 16.7 to 23.4 | Months | |
| Overall Survival (OS) | Sorafenib 400 mg | 19.2 | 95% Confidence Interval 17.5 to 22.3 | Months | |
| Objective Response Rate (ORR) | Axitinib 5 mg | 19.4 | 95% Confidence Interval 15.4 to 23.9 | Percentage of participants | |
| Objective Response Rate (ORR) | Sorafenib 400 mg | 9.4 | 95% Confidence Interval 6.6 to 12.9 | Percentage of participants | |
| Duration of Response (DR) | Axitinib 5 mg | 11.0 | 95% Confidence Interval 7.4 to NA | Months | |
| Duration of Response (DR) | Sorafenib 400 mg | 10.6 | 95% Confidence Interval 8.8 to 11.5 | Months | |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Axitinib 5 mg | AEs | 96.1 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Sorafenib 400 mg | AEs | 98.0 | Percentage of participants |
1 to 10 of 418Source ClinicalTrials.gov
See all 418 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 5 mg | 361 | |
| Overall Study | STARTED | Sorafenib 400 mg | 362 | |
| Overall Study | Treated | Axitinib 5 mg | 359 | |
| Overall Study | Treated | Sorafenib 400 mg | 355 | |
| Overall Study | COMPLETED | Axitinib 5 mg | 0 | |
| Overall Study | COMPLETED | Sorafenib 400 mg | 0 | |
| Overall Study | NOT COMPLETED | Axitinib 5 mg | 361 | |
| Overall Study | NOT COMPLETED | Sorafenib 400 mg | 362 |
Source ClinicalTrials.gov
Adverse events528
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 5 mg | 18 | 359 | |
| other | Anaemia | Blood and lymphatic system disorders | Sorafenib 400 mg | 44 | 355 | |
| other | Hypothyroidism | Endocrine disorders | Axitinib 5 mg | 74 | 359 | |
| other | Hypothyroidism | Endocrine disorders | Sorafenib 400 mg | 33 | 355 | |
| other | Abdominal pain | Gastrointestinal disorders | Axitinib 5 mg | 55 | 359 | |
| other | Abdominal pain | Gastrointestinal disorders | Sorafenib 400 mg | 46 | 355 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Axitinib 5 mg | 37 | 359 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sorafenib 400 mg | 16 | 355 | |
| other | Constipation | Gastrointestinal disorders | Axitinib 5 mg | 79 | 359 | |
| other | Constipation | Gastrointestinal disorders | Sorafenib 400 mg | 82 | 355 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Axitinib 5 mg | ||
| Total, all-cause mortality | Sorafenib 400 mg | ||
| Total, other adverse events | Axitinib 5 mg | 337 | 359 |
| Total, other adverse events | Sorafenib 400 mg | 346 | 355 |
| Total, serious adverse events | Axitinib 5 mg | 146 | 359 |
| Total, serious adverse events | Sorafenib 400 mg | 127 | 355 |
Source ClinicalTrials.gov
Papers11
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Axitinib 5 mg vs Sorafenib 400 mg: 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.
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