Trial · NCT00597116
An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
NCT00597116, Phase 2, Terminated, Genzyme, a Sanofi Company; results first posted 2012-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma. Trials, record NCT00597116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
- NCT number
- NCT00597116
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Mesothelioma
- Interventions
- Vinorelbine, Vandetanib
- First posted
- 2008-01-17
- Last updated
- 2016-10-10
- Other registries' IDs
- eudract:2007-003633-16
- Results first posted
- 2012-10-15
- Limitations and caveats
- Early termination leading to small number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Disease Control. | Assessed at 2 months. | Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD. |
| Secondary | Number of Participants With Objective Response. | Assessed at 2 months. | Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. |
| Secondary | Progression-free Survival (PFS) | Assessed from baseline to 12 months. | Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. |
| Secondary | Overall Survival (OS) | Assessed from baseline to 12 months. |
Source ClinicalTrials.gov
Outcomes4
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 Disease Control. | Assessed at 2 months. | Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Objective Response. | Assessed at 2 months. | Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment. | Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Assessed from baseline to 12 months. | Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Assessed from baseline to 12 months. | Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
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 Disease Control. | Vandetanib | 0 | 0 to 0 | Participants | |
| Number of Participants With Disease Control. | Vinorelbine | 5 | 0 to 0 | Participants | |
| Number of Participants With Objective Response. | Vandetanib | 0 | 0 to 0 | Participants | |
| Number of Participants With Objective Response. | Vinorelbine | 0 | 0 to 0 | Participants | |
| Progression-free Survival (PFS) | Vandetanib | 1.8 | 95% Confidence Interval 1.1 to 1.8 | Months | |
| Progression-free Survival (PFS) | Vinorelbine | 3.8 | 95% Confidence Interval 2.1 to 7.3 | Months | |
| Overall Survival (OS) | Vandetanib | 7.8 | 95% Confidence Interval 2.5 to 12.5 | Months | |
| Overall Survival (OS) | Vinorelbine | 6.4 | 95% Confidence Interval 3.6 to 14.9 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib | 14 | |
| Overall Study | STARTED | Vinorelbine | 11 | |
| Overall Study | COMPLETED | Vandetanib | 0 | |
| Overall Study | COMPLETED | Vinorelbine | 0 | |
| Overall Study | NOT COMPLETED | Vandetanib | 14 | |
| Overall Study | NOT COMPLETED | Vinorelbine | 11 |
Source ClinicalTrials.gov
Adverse events174
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 | Vandetanib | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Vinorelbine | 3 | 10 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Vandetanib | 0 | 13 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Vinorelbine | 1 | 10 | |
| other | Vertigo | Ear and labyrinth disorders | Vandetanib | 0 | 13 | |
| other | Vertigo | Ear and labyrinth disorders | Vinorelbine | 2 | 10 | |
| other | Ear Discomfort | Ear and labyrinth disorders | Vandetanib | 0 | 13 | |
| other | Ear Discomfort | Ear and labyrinth disorders | Vinorelbine | 1 | 10 | |
| other | Hypothyroidism | Endocrine disorders | Vandetanib | 0 | 13 | |
| other | Hypothyroidism | Endocrine disorders | Vinorelbine | 1 | 10 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib | ||
| Total, all-cause mortality | Vinorelbine | ||
| Total, other adverse events | Vandetanib | 13 | 13 |
| Total, other adverse events | Vinorelbine | 10 | 10 |
| Total, serious adverse events | Vandetanib | 6 | 13 |
| Total, serious adverse events | Vinorelbine | 3 | 10 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib vs Vinorelbine: Number of Participants With Disease Control. | Trial comparisons |
| Vandetanib vs Vinorelbine: Number of Participants With Objective Response. | Trial comparisons |
| Vandetanib vs Vinorelbine: serious adverse events | 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.
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/NCT00597116
GET https://conductscience.org/api/trials/v1/NCT00597116/events?page=2