Trial · NCT00126503

Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

NCT00126503, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-06-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer. Trials, record NCT00126503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00126503

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer
NCT number: NCT00126503
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 73 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Chromophobe Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage IV Renal Cell Cancer
Interventions: Bevacizumab, Sorafenib Tosylate, Pharmacological Study, Laboratory Biomarker Analysis
First posted: 2005-08-04
Last updated: 2015-01-15
Results first posted: 2013-06-28
Limitations and caveats: To depict results of this Phases I/II study accurately, each phase was entered as an ARM to enable separation of the data by phase. Events reported in the Adverse Event and Serious Adverse Event sections include AEs and SAEs from Phase I and Phase II

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)	at 28 days	The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) \< 500/mm3 for \> 7 days, ANC \< 1000/mm3 with fever \> 101 degrees Fahrenheit, platelet count \< 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) \>= Grade 3.
Primary	Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)	at 28 days	The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) \< 500/mm3 for \> 7 days, ANC \< 1000/mm3 with fever \> 101 degrees Fahrenheit, platelet count \< 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) \>= Grade 3.
Primary	Objective Response	Every 8 weeks to date of progression	Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive
Secondary	Overall Survival	on-study to date of expired or last date known alive	Months from date on-study to expired or last date known alive
Secondary	Progression-free Survival	on-study to date of progression or last date known alive without progression	Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)	at 28 days	Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab	mg	NUMBER
SECONDARY	Overall Survival	on-study to date of expired or last date known alive	All treated patients available for determination of overall survival. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.	months	MEDIAN
SECONDARY	Progression-free Survival	on-study to date of progression or last date known alive without progression	All patients who underwent treatment. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.	months	MEDIAN
PRIMARY	Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)	at 28 days	Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab	mg/kg	NUMBER
PRIMARY	Objective Response	Every 8 weeks to date of progression	Patients available for measurement of response to treatment with regimen. 7 Phase I and 4 Phase II patients were not available for measurement of response, respectively: disease progression (5, 2), complicating disease (1, 0), death on-study (1, 0), toxicity (0, 1), and alternative treatment (0, 1). All were counted as clinical progression.	participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)	Phase I		200		mg
Overall Survival	Phase I		24	Full Range 1 to 73	months
Overall Survival	Phase II		25	Full Range 5 to 59	months
Progression-free Survival	Phase I		11	Full Range 1 to 56	months
Progression-free Survival	Phase II		15	Full Range 1 to 49	months
Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)	Phase I		5		mg/kg
Objective Response	Phase I	Complete Response	0	5 to 48	participants
Objective Response	Phase II	Complete Response	0		participants
Objective Response	Phase I	Partial Response	23		participants
Objective Response	Phase II	Partial Response	3		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I	48
Overall Study	STARTED	Phase II	21
Overall Study	COMPLETED	Phase I	1
Overall Study	COMPLETED	Phase II	0
Overall Study	NOT COMPLETED	Phase I	47
Overall Study	NOT COMPLETED	Phase II	21

Source ClinicalTrials.gov

Adverse events408

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	allergic reaction/hypersensivity	Immune system disorders	Phase I	0	48	0
other	allergic reaction/hypersensivity	Immune system disorders	Phase II	1	21	1
other	allergic rhinitis	Immune system disorders	Phase I	18	48	33
other	allergic rhinitis	Immune system disorders	Phase II	10	21	10
other	ALT/SGPT (serum glutamine pyruvic transminase)	Investigations	Phase I	11	48	28
other	ALT/SGPT (serum glutamine pyruvic transminase)	Investigations	Phase II	4	21	9
other	Anorexia	Gastrointestinal disorders	Phase I	28	48	72
other	Anorexia	Gastrointestinal disorders	Phase II	10	21	11
other	AST, SGOT (serum glutamine oxaloacetic transminase)	Investigations	Phase I	11	48	30
other	AST, SGOT (serum glutamine oxaloacetic transminase)	Investigations	Phase II	4	21	9

1 to 10 of 408Source ClinicalTrials.gov

See all 408 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I
Total, all-cause mortality	Phase II
Total, other adverse events	Phase I	48	48
Total, other adverse events	Phase II	21	21
Total, serious adverse events	Phase I	17	48
Total, serious adverse events	Phase II	8	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
P30CA068485	Cancer Center Support Grant	PARK, BEN HO	VANDERBILT UNIVERSITY MEDICAL CENTER	NATIONAL CANCER INSTITUTE	1995 to 2025	NIH RePORTER
U01CA099177	Vanderbilt Phase I Translational Research Program	ROTHENBERG, MACE L	VANDERBILT UNIVERSITY	NATIONAL CANCER INSTITUTE	2003 to 2007	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Phase I vs Phase II: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00126503

GET https://conductscience.org/api/trials/v1/NCT00126503/events?page=2

API reference For AI assistants