Trial · NCT00514046
Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
NCT00514046, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer. Trials, record NCT00514046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
- NCT number
- NCT00514046
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Medullary Thyroid Carcinoma, Multiple Endocrine Neoplasia Type 2A, Multiple Endocrine Neoplasia Type 2B
- Interventions
- Vandetanib
- First posted
- 2007-08-09
- Last updated
- 2020-12-22
- Results first posted
- 2020-12-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | During Cycle 1 and Cycle 2, approximately 56 days | The MTD is the highest dose of Vandetanib tolerated at which a participant experienced a dose limiting toxicity (DLT) during the first two cycles of drug. |
| Primary | Overall Percentage of Participants With an Objective Response Defined as a Complete Response (CR) or Partial Response (PR) | Patients were evaluated for response after every 2 cycles x 4 (prior to cycles 1, 3, 5, 7, and 9) and then after every 4 cycles X 1 (prior to cycle 13) and then every 6 cycles (prior to cycle 19, 25, 31, etc). Response was followed for an median of 59 mon | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease 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. Progressive Disease 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. |
| Secondary | Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Every 2 cycles x 4 (prior to cycles 1, 3, 5, 7 and 9), prior to cycle 13, and then every 6 cycles (prior to cycle 19, 25, 31, etc). Patients were followed for response for a median of 59 months. | Blood was collected from participants and measured with an Axsym Analyzer then Immulite CEA method and assessed by the following response criteria. Partial Response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progression (P) is a ≥50% increase in the CEA relative to the prior value on 2 consecutive measurements at least 4 weeks apart. The patient must have been taking vandetanib for 4 weeks prior to the first measurements and must have continued to take the drug through the time that the second measurement was drawn. Stable (S) is a \<50% increase or decrease in CEA level relative to the baseline level. |
| Secondary | Percent Change in Calcitonin (CTN) Biomarker Response After Cycle 1 | Cycle 1 (28 days) | Blood was collected from participants and measured with an Chemiluminescence immunoassay. Calcitonin upper limit of normal is \<10 pg/mL. A decline in CTN is defined as a ≥50% increase (e.g. tumor growth or progression) in the CTN level after treatment in cycle 1. |
| Secondary | Area Under the Concentration Time Curve (AUC 0-24h) | Cycle 1, Pre-dose and then 1, 2, 4, 6, 8, 10 and 24 hour post dose. | The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | Date treatment consent signed to date off study, approximately 142 months and 8 days. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With a Dose Limiting Toxicity (DLT) | up to Cycle 3 (each Cycle is 28 days) | Hematologic Dose-Limiting Toxicity (H-DLT) is: Neutrophil count below 1,000/μL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a single neutrophil count below 500/μL (grade 4); Platelet count below 50,000/μL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a single platelet count below 25,000/μL (grade 4); A platelet transfusion administered when platelet count is below 50,000/μL is dose limiting thrombocytopenia, unless the transfusion is being administered for perioperative coverage; Grade 3 or 4 decrease in hemoglobin that can be corrected to at least 8.0 g/dl (grade 2) by transfusion of red blood cells is not a dose-limiting toxicity. Grade 3 or 4 hemolysis is a dose-limiting toxicity if it is judged to be vandetanib-related. Non-Hematologic Dose-Limiting Toxicity is any grade 3 or higher non-hematologic toxicity, with some exceptions such as Grade 3 nausea that is controlled by symptomatic treatment with anti-emetics. |
Source ClinicalTrials.gov
Outcomes7
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) | During Cycle 1 and Cycle 2, approximately 56 days | mg/m^2/day | NUMBER | |
| PRIMARY | Overall Percentage of Participants With an Objective Response Defined as a Complete Response (CR) or Partial Response (PR) | Patients were evaluated for response after every 2 cycles x 4 (prior to cycles 1, 3, 5, 7, and 9) and then after every 4 cycles X 1 (prior to cycle 13) and then every 6 cycles (prior to cycle 19, 25, 31, etc). Response was followed for an median of 59 mon | This is the analysis of all 17 patients across dosing groups. Because dosing for each patient was adjusted over time based on toxicity and often patients did not have a radiographic response until they had a number of cycles of treatment, we combined all dosing groups when calculating response rate. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Every 2 cycles x 4 (prior to cycles 1, 3, 5, 7 and 9), prior to cycle 13, and then every 6 cycles (prior to cycle 19, 25, 31, etc). Patients were followed for response for a median of 59 months. | Patients with CEA \<2x upper limit of normal at baseline were not evaluable for this measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Calcitonin (CTN) Biomarker Response After Cycle 1 | Cycle 1 (28 days) | This data was only analyzed after cycle 1 and was not collected from the patient who received 150mg/m\^2 dosing during cycle 1. All other patients received 100mg/m\^2 dosing during cycle 1. | percent change in calcitonin | NUMBER |
| SECONDARY | Area Under the Concentration Time Curve (AUC 0-24h) | Cycle 1, Pre-dose and then 1, 2, 4, 6, 8, 10 and 24 hour post dose. | All 11 subjects who had PK analysis were receiving a dose of 100mg/m\^2/dose at the time that the PK analysis was done. All participants are grouped together because this data was performed during cycle 1 and was not collected for the patient who received 150mg/m\^2 during cycle 1. | mcg*h/mL | MEDIAN |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | Date treatment consent signed to date off study, approximately 142 months and 8 days. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose Limiting Toxicity (DLT) | up to Cycle 3 (each Cycle is 28 days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group58
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) | All Participants | 100 | mg/m^2/day | ||
| Overall Percentage of Participants With an Objective Response Defined as a Complete Response (CR) or Partial Response (PR) | All Participants | 59 | 95% Confidence Interval 33 to 82 | percentage of participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib: First 100 mg/m^2, Then 150 mg/m^2 | <50% decrease/<50% increase | 1 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg | <50% decrease/<50% increase | 0 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib 100 mg/m^2 | <50% decrease/<50% increase | 1 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg | <50% decrease/<50% increase | 1 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2 | <50% decrease/<50% increase | 0 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib: First 100 mg/m^2, Then 70 mg/m^2 | <50% decrease/<50% increase | 0 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg | <50% decrease/<50% increase | 0 | Participants | |
| Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response | Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg | <50% decrease/<50% increase | 0 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib: First 100 mg/m^2, Then 150 mg/m^2 | 5 | |
| Overall Study | STARTED | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg | 1 | |
| Overall Study | STARTED | Vandetanib 100 mg/m^2 | 5 | |
| Overall Study | STARTED | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg | 1 | |
| Overall Study | STARTED | Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2 | 1 | |
| Overall Study | STARTED | Vandetanib: First 100 mg/m^2, Then 70 mg/m^2 | 1 | |
| Overall Study | STARTED | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg | 1 | |
| Overall Study | STARTED | Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg | 1 | |
| Overall Study | STARTED | Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg | 1 | |
| Overall Study | COMPLETED | Vandetanib: First 100 mg/m^2, Then 150 mg/m^2 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events2,295
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: First 100 mg/m^2, Then 150 mg/m^2 | 4 | 5 | 30 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg | 0 | 1 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib 100 mg/m^2 | 3 | 5 | 17 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg | 1 | 1 | 2 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2 | 1 | 1 | 2 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib: First 100 mg/m^2, Then 70 mg/m^2 | 1 | 1 | 8 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg | 1 | 1 | 3 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg | 1 | 1 | 5 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg | 1 | 1 | 4 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Vandetanib: First 100 mg/m^2, Then 150 mg/m^2 | 3 | 5 | 10 |
1 to 10 of 2,295Source ClinicalTrials.gov
See all 2,295 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib: First 100 mg/m^2, Then 150 mg/m^2 | 0 | 5 |
| Total, all-cause mortality | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg | 0 | 1 |
| Total, all-cause mortality | Vandetanib 100 mg/m^2 | 0 | 5 |
| Total, all-cause mortality | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg | 0 | 1 |
| Total, all-cause mortality | Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vandetanib: First 100 mg/m^2, Then 70 mg/m^2 | 0 | 1 |
| Total, all-cause mortality | Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg | 0 | 1 |
| Total, all-cause mortality | Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg | 0 | 1 |
| Total, all-cause mortality | Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg | 0 | 1 |
| Total, other adverse events | Vandetanib: First 100 mg/m^2, Then 150 mg/m^2 | 5 | 5 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers6
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/NCT00514046
GET https://conductscience.org/api/trials/v1/NCT00514046/results?page=2