Trial · NCT01876784
Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
NCT01876784, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2017-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer. Trials, record NCT01876784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876784
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy, Safety of Vandetanib in Patients With Differentiated Thyroid Cancer
- NCT number
- NCT01876784
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 238 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Differentiated Thyroid Cancer
- Interventions
- Vandetanib (SAR390530), Placebo
- First posted
- 2013-06-13
- Last updated
- 2024-07-23
- Other registries' IDs
- eudract:2013-000422-58
- Results first posted
- 2017-03-13
- Limitations and caveats
- This study was part of the drug acquisition where model-based PK analysis was not performed by the legacy company. Available PK descriptive statistics have been reported.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Randomization until disease progression or death, assessed every 12 weeks (up to 22 months) | The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (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. Analysis was performed by Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | From randomization to the date of death due to any cause (maximum duration: up to 42 months) | OS was defined as the time from the date of randomization until death due to any cause. In the absence of observation of death, survival time was censored to last date the participant is known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method. |
| Secondary | Randomized Treatment Period: Percent Change From Baseline in Tumor Size (TS) at Week 36 | Baseline, Week 36 | Tumor size was the sum of the longest diameters of the target lesions. Target lesions were measurable tumor lesions. Baseline was defined as the last evaluable assessment prior to starting treatment. |
| Secondary | Percentage of Participants With Objective Response | From randomization to the date of first documented tumor progression, or death due to any cause, whichever comes first (maximum duration: up to 42 months) | Objective Response was defined as the percentage (%) of participants with complete response or partial response. Per RECIST 1.1 criteria, complete response was defined as the disappearance of all target lesions since Baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to less than (\<)10 millimeters (mm). Partial response was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum of diameters. Progressive Disease was defined as at least at least a 20% increase and absolute increase of 5 mm 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 | Time to Worsening of Pain (TWP) Using Numeric Rating Scale (NRS) of Worst Pain | From randomization to the date of first assessment of worsening of pain (maximum duration: up to 42 months) | Time to worsening of pain was defined as the time interval from the date of randomization to the date of first assessment of worsening of pain with no evidence of improvement within the next 14 days. Participants rate their worst pain intensity during the past seven days using an 11-point NRS scale, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Higher scores indicated greater pain severity. TWP analysis was performed using Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) | From the date of first response to the date of first documented tumor progression or death due to any cause whichever comes first (maximum duration: up to 42 months) | Duration of response was defined as the time from the date of first documented response until the date of documented progression or death. If participants did not progress following a response, then their DOR used the PFS censoring time. Per RECIST 1.1, progressive disease was defined as at least a 20% increase and absolute increase of 5 mm 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. DOR analysis was performed using Kaplan-Meier method. |
| Secondary | Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax) | Post-dose on Week 1 to Week 48 |
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 | Progression-Free Survival (PFS) | Randomization until disease progression or death, assessed every 12 weeks (up to 22 months) | Intent to treat population included all randomized participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death due to any cause (maximum duration: up to 42 months) | Analysis was performed on intent-to-treat population. | months | MEDIAN |
| SECONDARY | Randomized Treatment Period: Percent Change From Baseline in Tumor Size (TS) at Week 36 | Baseline, Week 36 | Analysis was performed on intent-to-treat population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Objective Response | From randomization to the date of first documented tumor progression, or death due to any cause, whichever comes first (maximum duration: up to 42 months) | Analysis was performed on intent-to-treat population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Time to Worsening of Pain (TWP) Using Numeric Rating Scale (NRS) of Worst Pain | From randomization to the date of first assessment of worsening of pain (maximum duration: up to 42 months) | Analysis was performed on intent-to-treat population. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the date of first response to the date of first documented tumor progression or death due to any cause whichever comes first (maximum duration: up to 42 months) | Analysis was performed on subset of participants with response. Here, '0' in 'overall number of participants' analyzed signifies that no participant in the Placebo/Vandetanib achieved any response, therefore DOR was not analyzed. | months | MEDIAN |
| SECONDARY | Randomized Treatment Period: PK Parameters: Maximum Plasma Concentration (Cmax) | Post-dose on Week 1 to Week 48 | Number of participants analyzed= participants with available data for the time points. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Randomized Treatment Period: Vandetanib | 10.0 | 95% Confidence Interval 6.0 to 11.1 | months | |
| Progression-Free Survival (PFS) | Randomized Treatment Period: Placebo | 5.7 | 95% Confidence Interval 5.5 to 8.4 | months | |
| Overall Survival (OS) | Vandetanib/Vandetanib | NA | 95% Confidence Interval 31.6 to NA | months | |
| Overall Survival (OS) | Placebo/Vandetanib | NA | 95% Confidence Interval 32.1 to NA | months | |
| Randomized Treatment Period: Percent Change From Baseline in Tumor Size (TS) at Week 36 | Randomized Treatment Period: Vandetanib | 23.29 | Standard Deviation 50.059 | percent change | |
| Randomized Treatment Period: Percent Change From Baseline in Tumor Size (TS) at Week 36 | Randomized Treatment Period: Placebo | 21.52 | Standard Deviation 25.428 | percent change | |
| Percentage of Participants With Objective Response | Vandetanib/Vandetanib | 5.0 | percentage of participants | ||
| Percentage of Participants With Objective Response | Placebo/Vandetanib | 0 | percentage of participants | ||
| Time to Worsening of Pain (TWP) Using Numeric Rating Scale (NRS) of Worst Pain | Vandetanib/Vandetanib | 5.6 | 95% Confidence Interval 2.9 to 8.4 | months | |
| Time to Worsening of Pain (TWP) Using Numeric Rating Scale (NRS) of Worst Pain | Placebo/Vandetanib | 8.3 | 95% Confidence Interval 2.8 to 16.6 | months |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Treatment Period (40 Months) | STARTED | Vandetanib/Vandetanib | 119 | |
| Randomized Treatment Period (40 Months) | STARTED | Placebo/Vandetanib | 119 | |
| Randomized Treatment Period (40 Months) | Treated | Vandetanib/Vandetanib | 117 | |
| Randomized Treatment Period (40 Months) | Treated | Placebo/Vandetanib | 118 | |
| Randomized Treatment Period (40 Months) | COMPLETED | Vandetanib/Vandetanib | 0 | |
| Randomized Treatment Period (40 Months) | COMPLETED | Placebo/Vandetanib | 0 | |
| Randomized Treatment Period (40 Months) | NOT COMPLETED | Vandetanib/Vandetanib | 119 | |
| Randomized Treatment Period (40 Months) | NOT COMPLETED | Placebo/Vandetanib | 119 | |
| Open-label Period (31 Months) | STARTED | Vandetanib/Vandetanib | 23 | |
| Open-label Period (31 Months) | STARTED | Placebo/Vandetanib | 74 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events588
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 | Anaemia | Blood and lymphatic system disorders | Randomized Treatment Period: Vandetanib | 6 | 117 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Randomized Treatment Period: Placebo | 6 | 118 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Treatment Period: Vandetanib/Vandetanib | 1 | 23 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Treatment Period: Placebo/Vandetanib | 0 | 74 | 0 |
| other | Cornea Verticillata | Eye disorders | Randomized Treatment Period: Vandetanib | 9 | 117 | 9 |
| other | Cornea Verticillata | Eye disorders | Randomized Treatment Period: Placebo | 0 | 118 | 0 |
| other | Cornea Verticillata | Eye disorders | Open-Label Treatment Period: Vandetanib/Vandetanib | 1 | 23 | 1 |
| other | Cornea Verticillata | Eye disorders | Open-Label Treatment Period: Placebo/Vandetanib | 4 | 74 | 4 |
| other | Abdominal Pain | Gastrointestinal disorders | Randomized Treatment Period: Vandetanib | 8 | 117 | 9 |
| other | Abdominal Pain | Gastrointestinal disorders | Randomized Treatment Period: Placebo | 8 | 118 | 9 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Treatment Period: Vandetanib | ||
| Total, all-cause mortality | Randomized Treatment Period: Placebo | ||
| Total, all-cause mortality | Open-Label Treatment Period: Vandetanib/Vandetanib | ||
| Total, all-cause mortality | Open-Label Treatment Period: Placebo/Vandetanib | ||
| Total, other adverse events | Randomized Treatment Period: Vandetanib | 111 | 117 |
| Total, other adverse events | Randomized Treatment Period: Placebo | 87 | 118 |
| Total, other adverse events | Open-Label Treatment Period: Vandetanib/Vandetanib | 9 | 23 |
| Total, other adverse events | Open-Label Treatment Period: Placebo/Vandetanib | 62 | 74 |
| Total, serious adverse events | Randomized Treatment Period: Vandetanib | 37 | 117 |
| Total, serious adverse events | Randomized Treatment Period: Placebo | 19 | 118 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01876784
GET https://conductscience.org/api/trials/v1/NCT01876784/events?page=2