Trial · NCT01372813
Vandetanib to Treat Advanced Kidney Cancer
NCT01372813, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2012-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vandetanib to Treat Advanced Kidney Cancer. Trials, record NCT01372813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01372813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vandetanib to Treat Advanced Kidney Cancer
- NCT number
- NCT01372813
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Advanced Clear Cell Renal Carcinoma
- Interventions
- vandetanib
- First posted
- 2011-06-14
- Last updated
- 2015-10-23
- Results first posted
- 2012-03-12
- Limitations and caveats
- Study was designed to accrue up to 37 patients but only 3 were enrolled. Study was terminated due to low accrual.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR)) | 12 months | Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions. |
| Secondary | Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2) | 12 months | Plasma VEGFR and VEGFR2 would have been measured using the (enzyme-linked immunosorbent assay)ELISA at baseline and specified timepoints following initiation of therapy. |
| Secondary | Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment | 12 months | CEP cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10\^5 cellular events, and preferably 10\^6 cellular events. |
| Secondary | Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | 12 months | Progression free survival is defined as the time from initiation of treatment to either progression or death. RECIST evaluates tumor response. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For detailed information about RECIST, see the protocol Link module. |
| Secondary | Number of Participants With Adverse Events | 11.5 months | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
| Secondary | Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment | 12 months | CEC cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10\^5 cellular events, and preferably 10\^6 cellular events. |
| Secondary | Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) | 12 months | Flow dynamics within specific tumor sites will be evaluated based on the results of the DCE-MRI obtained first without contrast enhancement and then after contrast enhancement. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters previously defined (Ktrans, Kep, etc.). |
| Secondary | Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway | 12 months | Components of the VEGF and EGFR pathways were to be evaluated using Western blot analysis at baseline and specified timepoints following initiation of therapy when tumor tissue was available. |
| Secondary | The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density | 12 months | Tumor tissue sections were to be stained with hematoxylin and eosin (H and E) and endothelial cell markers at baseline and specified timepoints following initiation of therapy (when tumor tissue was available) |
| Secondary | Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib) | 12 months | If an adequate number of responses were seen, the relation of these responses to the presence/absence of inactivating VHL mutations in tumor tissue would have been assessed. |
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 | Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR)) | 12 months | Participants | NUMBER | |
| SECONDARY | Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2) | 12 months | Not enough samples for meaningful analysis. | ||
| SECONDARY | Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment | 12 months | Not enough samples for meaningful analysis. | ||
| SECONDARY | Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | 12 months | Days | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | 11.5 months | Participants | NUMBER | |
| SECONDARY | Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment | 12 months | Not enough samples for meaningful analysis. | ||
| SECONDARY | Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) | 12 months | Participants with changes | NUMBER | |
| SECONDARY | Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway | 12 months | Not enough samples for meaningful analysis. | ||
| SECONDARY | The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density | 12 months | Not enough samples for meaningful analysis. | ||
| SECONDARY | Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib) | 12 months | Not enough samples for meaningful analysis. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR)) | Clear Cell Renal Carcinoma Patients | 0 | Participants | ||
| Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Clear Cell Renal Carcinoma Patients | 55 | 95% Confidence Interval 51 to 111 | Days | |
| Number of Participants With Adverse Events | Clear Cell Renal Carcinoma Patients | 3 | Participants | ||
| Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) | Clear Cell Renal Carcinoma Patients | 0 | Participants with changes |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clear Cell Renal Carcinoma Patients | 3 | |
| Overall Study | COMPLETED | Clear Cell Renal Carcinoma Patients | 3 | |
| Overall Study | NOT COMPLETED | Clear Cell Renal Carcinoma Patients | 0 |
Source ClinicalTrials.gov
Adverse events18
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) | Investigations | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Alkaline phosphatase | Investigations | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Bicarbonate, serum-low | Investigations | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Creatinine | Investigations | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Hypertension | Vascular disorders | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
| other | Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | Clear Cell Renal Carcinoma Patients | 1 | 3 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clear Cell Renal Carcinoma Patients | ||
| Total, other adverse events | Clear Cell Renal Carcinoma Patients | 3 | 3 |
| Total, serious adverse events | Clear Cell Renal Carcinoma Patients | 1 | 3 |
Source ClinicalTrials.gov
Papers3
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/NCT01372813
GET https://conductscience.org/api/trials/v1/NCT01372813/registered