Trial · NCT00566995
Phase II Study of Vandetanib in Individuals With Kidney Cancer
NCT00566995, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Vandetanib in Individuals With Kidney Cancer. Trials, record NCT00566995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00566995
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Vandetanib in Individuals With Kidney Cancer
- NCT number
- NCT00566995
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Renal Cancer, Von Hippel Lindau
- Interventions
- ZACTIMA (Vandetanib) (ZD6474)
- First posted
- 2007-12-04
- Last updated
- 2018-10-30
- Results first posted
- 2015-03-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate. | Baseline and every 3 cycles, up to 2 years | Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. |
| Secondary | Number of Participants With Adverse Events | 72 months and 14 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Time To Progression (TTP) | Baseline and every 3 cycles while on study, up to 2 years. | Time to progression is defined as the time from the start of treatment to progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, with death being treated as a censored event. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new lesions, developing a surgical size tumor that should be resected. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. |
| Secondary | Progression Free Survival (PFS) | Baseline and every 3 cycles while on study, up to 2 years. | Progression free survival is defined as time from initiation of treatment to either progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. |
| Secondary | Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells | Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days) | Peripheral blood was collected and analyzed by multiparametric flow cytometry for analysis of angiogenesis markers. |
| Secondary | Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC) | Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days) | Peripheral blood was collected and analyzed by multiparametric flow cytometry. |
| Secondary | Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL) | Baseline and every 3 cycles while on study, up to 2 years. | Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL) | Baseline and every 3 cycles while on study, up to 2 years. | Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Response in Pheochromocytomas Associated With Von Hippel Lindau (VHL) | Baseline and every 3 cycles while on study, up to 2 years. | Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Other | Change in Plasma Biomarkers Vascular Endothelial Growth Factor (VEGF) and Soluble Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Before and After Treatment With Vandetanib | Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days) | 5-10cc venous blood was collected for evaluation of basal plasma levels of angiogenesis biomarkers VEGF and VEGFR-2. |
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 Response Rate. | Baseline and every 3 cycles, up to 2 years | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | 72 months and 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time To Progression (TTP) | Baseline and every 3 cycles while on study, up to 2 years. | Months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | Baseline and every 3 cycles while on study, up to 2 years. | Months | MEDIAN | |
| SECONDARY | Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells | Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days) | No samples were received for 2/37 patients. | Cells per 10^6 mononuclear cells | MEDIAN |
| SECONDARY | Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC) | Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days) | No samples were received for 2/37 participants. | CEC per 10^6 mononuclear cells | MEDIAN |
| SECONDARY | Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL) | Baseline and every 3 cycles while on study, up to 2 years. | Only two participants had target lesions that could be measured. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL) | Baseline and every 3 cycles while on study, up to 2 years. | Only two participants had target lesions that could be measured. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response in Pheochromocytomas Associated With Von Hippel Lindau (VHL) | Baseline and every 3 cycles while on study, up to 2 years. | This outcome measure was not done because no participants had measurable lesions. | ||
| OTHER_PRE_SPECIFIED | Change in Plasma Biomarkers Vascular Endothelial Growth Factor (VEGF) and Soluble Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Before and After Treatment With Vandetanib | Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days) | This analysis was intended to be exploratory. Several other studies established that therapy with VEGFR agents modulated serum/plasma VEGF and soluble VEGFR2 levels, but there was no consistent \& established correlation with clinical outcome. These analyses were unlikely to add further to our ability to evaluate the major objectives of the study. |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate. | Vandetanib in Participants With Kidney Cancer | Partial Response | 3 | percentage of participants | |
| Overall Response Rate. | Vandetanib in Participants With Kidney Cancer | Complete Response | 0 | percentage of participants | |
| Overall Response Rate. | Vandetanib in Participants With Kidney Cancer | Stable Disease | 75 | percentage of participants | |
| Overall Response Rate. | Vandetanib in Participants With Kidney Cancer | Progressive Disease | 0 | percentage of participants | |
| Overall Response Rate. | Vandetanib in Participants With Kidney Cancer | Not Evaluable | 22 | percentage of participants | |
| Number of Participants With Adverse Events | Vandetanib in Participants With Kidney Cancer | 37 | Participants | ||
| Time To Progression (TTP) | Vandetanib in Participants With Kidney Cancer | 13.8 | 95% Confidence Interval 11.0 to 22.1 | Months | |
| Progression Free Survival (PFS) | Vandetanib in Participants With Kidney Cancer | 13.8 | 95% Confidence Interval 11.0 to 22.1 | Months | |
| Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells | Vandetanib in Participants With Kidney Cancer | Cycle 1 Day 1 Pre treatment | 214.44 | Full Range 0 to 906.7 | Cells per 10^6 mononuclear cells |
| Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells | Vandetanib in Participants With Kidney Cancer | Cycle 1 Day 1, 4 hours post | 115.79 | Full Range 0 to 282.69 | Cells per 10^6 mononuclear cells |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib in Participants With Kidney Cancer | 37 | |
| Overall Study | COMPLETED | Vandetanib in Participants With Kidney Cancer | 30 | |
| Overall Study | NOT COMPLETED | Vandetanib in Participants With Kidney Cancer | 7 |
Source ClinicalTrials.gov
Adverse events148
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 24 | 37 | 75 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 17 | 37 | 37 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 17 | 37 | 33 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 13 | 37 | 26 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Vandetanib in Participants With Kidney Cancer | 3 | 37 | 3 |
| other | Anorexia | Gastrointestinal disorders | Vandetanib in Participants With Kidney Cancer | 2 | 37 | 2 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Vandetanib in Participants With Kidney Cancer | 1 | 37 | 1 |
| other | Bicarbonate, serum-low | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 6 | 37 | 6 |
| other | Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 5 | 37 | 8 |
| other | CPK (creatine phosphokinase) | Metabolism and nutrition disorders | Vandetanib in Participants With Kidney Cancer | 15 | 37 | 31 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib in Participants With Kidney Cancer | 0 | 37 |
| Total, other adverse events | Vandetanib in Participants With Kidney Cancer | 37 | 37 |
| Total, serious adverse events | Vandetanib in Participants With Kidney Cancer | 5 | 37 |
Source ClinicalTrials.gov
Papers4
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
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