NCT00678392 is a Phase 3 clinical trial of Axitinib (AG-013736) in Kidney Neoplasms, sponsored by Pfizer.

Who is sponsoring NCT00678392?

NCT00678392 is sponsored by Pfizer.

What drugs are being tested in NCT00678392?

Interventions in NCT00678392: Axitinib (AG-013736), Sorafenib.

What condition does NCT00678392 study?

NCT00678392 studies Kidney Neoplasms.

Is NCT00678392 still recruiting?

NCT00678392 is currently completed. Last updated 9 January 2019.

Are results published for NCT00678392?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-09 · How we verify

NCT00678392

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Completed Phase 3 Results posted Last updated 9 January 2019

What this trial tests

Phase 3 trial testing Axitinib (AG-013736) in Kidney Neoplasms in 723 participants. Completed in 25 February 2016.

Timeline

3 September 2008

Primary endpoint
31 August 2010

25 February 2016

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	723
Start date	3 September 2008
Primary completion	31 August 2010
Estimated completion	25 February 2016
Sites	294 locations across Italy, Japan, Taiwan, Ireland, Poland, South Korea, Russia, Sweden

Drugs / interventions tested

Axitinib (AG-013736) (axitinib-ag-013736) — full drug profile →
Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

Kidney Neoplasms — all drugs for Kidney Neoplasms →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Kidney Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-Free Survival (PFS) Primary · 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

Group	Value	95% CI
Axitinib 5 mg	6.7	6.3 – 8.6
Sorafenib 400 mg	4.7	4.6 – 5.6

Overall Survival (OS) Secondary · 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.

Group	Value	95% CI
Axitinib 5 mg	20.1	16.7 – 23.4
Sorafenib 400 mg	19.2	17.5 – 22.3

Objective Response Rate (ORR) Secondary · 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 r

Group	Value	95% CI
Axitinib 5 mg	19.4	15.4 – 23.9
Sorafenib 400 mg	9.4	6.6 – 12.9

Duration of Response (DR) Secondary · 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

Group	Value	95% CI
Axitinib 5 mg	11.0	7.4 – NA
Sorafenib 400 mg	10.6	8.8 – 11.5

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · 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 pre

AEs

Group	Value	95% CI
Axitinib 5 mg	96.1
Sorafenib 400 mg	98.0

SAEs

Group	Value	95% CI
Axitinib 5 mg	40.7
Sorafenib 400 mg	35.8

Percentage of Participants With Adverse Events (AEs) by Severity Secondary · 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.

Grade 1

Group	Value	95% CI
Axitinib 5 mg	3.9
Sorafenib 400 mg	3.1

Grade 2

Group	Value	95% CI
Axitinib 5 mg	20.1
Sorafenib 400 mg	21.7

Grade 3

Group	Value	95% CI
Axitinib 5 mg	47.6
Sorafenib 400 mg	52.4

Grade 4

Group	Value	95% CI
Axitinib 5 mg	10.6
Sorafenib 400 mg	11.5

Grade 5

Group	Value	95% CI
Axitinib 5 mg	13.9
Sorafenib 400 mg	9.3

Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · 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.

AEs

Group	Value	95% CI
Axitinib 5 mg	92.2
Sorafenib 400 mg	95.2

SAEs

Group	Value	95% CI
Axitinib 5 mg	15.3
Sorafenib 400 mg	13.8

Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology Secondary · 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.

Hemoglobin: Grade 1 (n =320, 316)

Group	Value	95% CI
Axitinib 5 mg	93
Sorafenib 400 mg	112

Hemoglobin: Grade 2 (n =320, 316)

Group	Value	95% CI
Axitinib 5 mg	19
Sorafenib 400 mg	41

Hemoglobin: Grade 3 (n =320, 316)

Group	Value	95% CI
Axitinib 5 mg	1
Sorafenib 400 mg	11

Hemoglobin: Grade 4 (n =320, 316)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	1

Lymphocytes: Grade 1 (n =317, 309)

Group	Value	95% CI
Axitinib 5 mg	7
Sorafenib 400 mg	7

Lymphocytes: Grade 2 (n =317, 309)

Group	Value	95% CI
Axitinib 5 mg	89
Sorafenib 400 mg	93

Lymphocytes: Grade 3 (n =317, 309)

Group	Value	95% CI
Axitinib 5 mg	10
Sorafenib 400 mg	11

Lymphocytes: Grade 4 (n =317, 309)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	0

Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry Secondary · 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.

Alanine aminotransferase: Grade 1 (n =331, 313)

Group	Value	95% CI
Axitinib 5 mg	65
Sorafenib 400 mg	57

Alanine aminotransferase: Grade 2 (n =331, 313)

Group	Value	95% CI
Axitinib 5 mg	8
Sorafenib 400 mg	6

Alanine aminotransferase: Grade 3 (n =331, 313)

Group	Value	95% CI
Axitinib 5 mg	1
Sorafenib 400 mg	2

Alanine aminotransferase: Grade 4 (n =331, 313)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	3

Alkaline phosphatase: Grade 1 (n =336, 319)

Group	Value	95% CI
Axitinib 5 mg	88
Sorafenib 400 mg	92

Alkaline phosphatase: Grade 2 (n =336, 319)

Group	Value	95% CI
Axitinib 5 mg	8
Sorafenib 400 mg	15

Alkaline phosphatase: Grade 3 (n =336, 319)

Group	Value	95% CI
Axitinib 5 mg	4
Sorafenib 400 mg	3

Alkaline phosphatase: Grade 4 (n =336, 319)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	0

Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis Secondary · 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.

Urine blood/ hemoglobin: Grade 1 (n =304, 272)

Group	Value	95% CI
Axitinib 5 mg	45
Sorafenib 400 mg	35

Urine blood/ hemoglobin: Grade 2 (n =304, 272)

Group	Value	95% CI
Axitinib 5 mg	1
Sorafenib 400 mg	0

Urine blood/ hemoglobin: Grade 3 (n =304, 272)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	0

Urine blood/ hemoglobin: Grade 4 (n =304, 272)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	0

Urine glucose: Grade 1 (n =322, 286)

Group	Value	95% CI
Axitinib 5 mg	12
Sorafenib 400 mg	13

Urine glucose: Grade 2 (n =322, 286)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	3

Urine glucose: Grade 3 (n =322, 286)

Group	Value	95% CI
Axitinib 5 mg	0
Sorafenib 400 mg	0

Urine glucose: Grade 4 (n =322, 286)

Group	Value	95% CI
Axitinib 5 mg	1
Sorafenib 400 mg	1

Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score Secondary · Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indi

Baseline (n =346, 342)

Group	Value	95% CI
Axitinib 5 mg	43.199	± 8.416
Sorafenib 400 mg	43.339	± 8.162

Cycle 2/Day1 (n =319, 296)

Group	Value	95% CI
Axitinib 5 mg	42.351	± 8.305
Sorafenib 400 mg	41.668	± 7.696

Cycle 3/Day1 (n =279, 246)

Group	Value	95% CI
Axitinib 5 mg	42.590	± 7.729
Sorafenib 400 mg	42.424	± 7.888

Cycle 4/Day1 (n =257, 221)

Group	Value	95% CI
Axitinib 5 mg	42.791	± 8.180
Sorafenib 400 mg	43.424	± 7.345

Cycle 5/Day1 (n =238, 203)

Group	Value	95% CI
Axitinib 5 mg	42.968	± 8.152
Sorafenib 400 mg	42.907	± 7.255

Cycle 6/Day1 (n =213, 179)

Group	Value	95% CI
Axitinib 5 mg	42.949	± 7.842
Sorafenib 400 mg	43.057	± 7.724

Cycle 7/Day1 (n =206, 158)

Group	Value	95% CI
Axitinib 5 mg	42.747	± 7.621
Sorafenib 400 mg	43.578	± 7.621

Cycle 8/Day1 (n =177, 136)

Group	Value	95% CI
Axitinib 5 mg	43.580	± 7.578
Sorafenib 400 mg	44.074	± 7.757

Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score Secondary · Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.

Baseline (n =346, 341)

Group	Value	95% CI
Axitinib 5 mg	28.874	± 5.187
Sorafenib 400 mg	28.975	± 5.193

Cycle 2/Day1 (n =319, 295)

Group	Value	95% CI
Axitinib 5 mg	28.211	± 4.920
Sorafenib 400 mg	28.399	± 5.064

Cycle 3/Day1 (n =279, 244)

Group	Value	95% CI
Axitinib 5 mg	28.640	± 4.837
Sorafenib 400 mg	28.640	± 4.868

Cycle 4/Day1 (n =257, 220)

Group	Value	95% CI
Axitinib 5 mg	28.822	± 4.952
Sorafenib 400 mg	29.130	± 4.322

Cycle 5/Day1 (n =238, 202)

Group	Value	95% CI
Axitinib 5 mg	28.869	± 4.880
Sorafenib 400 mg	29.007	± 4.379

Cycle 6/Day1 (n =213, 178)

Group	Value	95% CI
Axitinib 5 mg	29.159	± 4.462
Sorafenib 400 mg	29.098	± 4.697

Cycle 7/Day1 (n =206, 157)

Group	Value	95% CI
Axitinib 5 mg	29.042	± 4.581
Sorafenib 400 mg	29.361	± 4.558

Cycle 8/Day1 (n =177, 135)

Group	Value	95% CI
Axitinib 5 mg	29.520	± 4.346
Sorafenib 400 mg	29.619	± 4.386

Adverse events — posted to ClinicalTrials.gov

Time frame: From initiation of treatment up to follow-up period (up to 3 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Axitinib 5 mg

Serious: 146/359 (41%)

Deaths: —

Sorafenib 400 mg

Serious: 127/355 (36%)

Deaths: —

Serious adverse events (214 terms)

Reaction	System	Axitinib 5 mg	Sorafenib 400 mg
Disease progression	General disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Death	General disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
General physical health deterioration	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Vascular disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Pain	General disorders	—	—
Infection	Infections and infestations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—

Other adverse events (50 terms — click to expand)

Reaction	System	Axitinib 5 mg	Sorafenib 400 mg
Diarrhoea	Gastrointestinal disorders	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Fatigue	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—
Weight decreased	Investigations	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Mucosal inflammation	General disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Dysgeusia	Nervous system disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Pyrexia	General disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Chest pain	General disorders	—	—
Oedema peripheral	General disorders	—	—

Most-reported serious reactions: Disease progression, Dehydration, Anaemia, Diarrhoea, Pyrexia, Dyspnoea, Pulmonary embolism, Myocardial infarction.

Data from ClinicalTrials.gov NCT00678392 adverse events section.

Sponsor's own description

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial.
Rini BI, Escudier B, Tomczak P, Kaprin A, et al · · 2011 · cited 1352× · PMID 22056247 · DOI 10.1016/s0140-6736(11)61613-9
Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial.
Motzer RJ, Escudier B, Tomczak P, Hutson TE, et al · · 2013 · cited 519× · PMID 23598172 · DOI 10.1016/s1470-2045(13)70093-7
Recent advances on anti-angiogenesis receptor tyrosine kinase inhibitors in cancer therapy.
Qin S, Li A, Yi M, Yu S, et al · · 2019 · cited 221× · PMID 30866992 · DOI 10.1186/s13045-019-0718-5
Body Mass Index and Metastatic Renal Cell Carcinoma: Clinical and Biological Correlations.
Albiges L, Hakimi AA, Xie W, McKay RR, et al · · 2016 · cited 165× · PMID 27601543 · DOI 10.1200/jco.2016.66.7311
Anti-VEGF therapies in the clinic.
Meadows KL, Hurwitz HI. · · 2012 · cited 165× · PMID 23028128 · DOI 10.1101/cshperspect.a006577
Tumor stroma as targets for cancer therapy.
Zhang J, Liu J. · · 2013 · cited 139× · PMID 23064233 · DOI 10.1016/j.pharmthera.2012.10.003
Toxicity as a biomarker of efficacy of molecular targeted therapies: focus on EGFR and VEGF inhibiting anticancer drugs.
Dienstmann R, Braña I, Rodon J, Tabernero J. · · 2011 · cited 108× · PMID 22135123 · DOI 10.1634/theoncologist.2011-0163
Angiotensin system inhibitors and survival outcomes in patients with metastatic renal cell carcinoma.
McKay RR, Rodriguez GE, Lin X, Kaymakcalan MD, et al · · 2015 · cited 103× · PMID 25724518 · DOI 10.1158/1078-0432.ccr-14-2332

Verify or expand the search:

Other trials of Axitinib (AG-013736)

Trials testing the same drug.

NCT03472560 — A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Med · Phase 2 · terminated
NCT03289533 — A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100) · Phase 1 · completed
NCT02684006 — A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Phase 3 · completed
NCT02493751 — A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100) · Phase 1 · completed
NCT01967576 — Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresecta · Phase 2 · completed

Other recruiting trials for Kidney Neoplasms

Currently open trials in the same condition.

NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting
NCT06536439 — Planning Operative Strategy Using a Digital Renal Artery Clamping Tool · NA · recruiting
NCT06715878 — Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage · NA · recruiting
NCT05218811 — Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach · NA · recruiting
NCT06126159 — MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histolo · NA · active not recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00678392 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 9 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00678392.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing