Trial · NCT00777179
Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
NCT00777179, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2011-07-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy. Trials, record NCT00777179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00777179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
- NCT number
- NCT00777179
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 117 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- NSCLC
- Interventions
- Vandetanib, Placebo
- First posted
- 2008-10-22
- Last updated
- 2016-10-10
- Results first posted
- 2011-07-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Rate at 3 Months | 12 weeks | Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients. |
| Secondary | Progression-free Survival (PFS) | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. | Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression. |
| Secondary | Overall Survival (OS) | Every 12 weeks unless the patient withdraws consent | Overall survival (OS) defined as the median time from randomization to death from any cause. |
| Secondary | Disease of Response (DOR) | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. | Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response |
| Secondary | Objective Response Rate (ORR) | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. | Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response. |
Source ClinicalTrials.gov
Outcomes5
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) Rate at 3 Months | 12 weeks | The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set. | Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Every 12 weeks unless the patient withdraws consent | months | MEDIAN | |
| SECONDARY | Disease of Response (DOR) | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. | Participants | NUMBER | |
| SECONDARY | Objective Response Rate (ORR) | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
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) Rate at 3 Months | Vandetanib | 28 | Participants | ||
| Progression-free Survival (PFS) Rate at 3 Months | Placebo | 12 | Participants | ||
| Progression-free Survival (PFS) | Vandetanib | 2.7 | 95% Confidence Interval 1.9 to 4.4 | months | |
| Progression-free Survival (PFS) | Placebo | 1.7 | 95% Confidence Interval 0.9 to 2.6 | months | |
| Overall Survival (OS) | Vandetanib | 15.6 | 95% Confidence Interval 9.6 to NA | months | |
| Overall Survival (OS) | Placebo | 20.8 | 95% Confidence Interval 15.2 to NA | months | |
| Disease of Response (DOR) | Vandetanib | 33 | Participants | ||
| Disease of Response (DOR) | Placebo | 17 | Participants | ||
| Objective Response Rate (ORR) | Vandetanib | 14 | Participants | ||
| Objective Response Rate (ORR) | Placebo | 1 | Participants |
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 | 75 | |
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | COMPLETED | Vandetanib | 75 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | NOT COMPLETED | Vandetanib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events124
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 | Diarrhoea | Gastrointestinal disorders | Vandetanib | 45 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 42 | |
| other | Nausea | Gastrointestinal disorders | Vandetanib | 13 | 75 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 42 | |
| other | Anorexia | Metabolism and nutrition disorders | Vandetanib | 29 | 75 | |
| other | Anorexia | Metabolism and nutrition disorders | Placebo | 7 | 42 | |
| other | Insomnia | Psychiatric disorders | Vandetanib | 14 | 75 | |
| other | Insomnia | Psychiatric disorders | Placebo | 2 | 42 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Vandetanib | 38 | 75 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 23 | 42 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 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 | Placebo | ||
| Total, other adverse events | Vandetanib | 72 | 75 |
| Total, other adverse events | Placebo | 37 | 42 |
| Total, serious adverse events | Vandetanib | 18 | 75 |
| Total, serious adverse events | Placebo | 4 | 42 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib vs Placebo: Disease of Response (DOR) | Trial comparisons |
| Vandetanib vs Placebo: Objective Response Rate (ORR) | Trial comparisons |
| Vandetanib vs Placebo: Progression-free Survival (PFS) Rate at 3 Months | Trial comparisons |
| Vandetanib vs Placebo: 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/NCT00777179
GET https://conductscience.org/api/trials/v1/NCT00777179/events?page=2