Trial · NCT00404924
ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
NCT00404924, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2012-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures. Trials, record NCT00404924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00404924
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
- NCT number
- NCT00404924
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,140 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Non-Small-Cell Lung Carcinoma
- Interventions
- ZD6474 (vandetanib), Best Supportive Care
- First posted
- 2006-11-29
- Last updated
- 2016-09-30
- Other registries' IDs
- eudract:2006-002384-12
- Results first posted
- 2012-03-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Time to death in months | Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown). |
| Secondary | Progression-Free Survival (PFS) | RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression | Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment |
| Secondary | Objective Response Rate (ORR) | Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression. | The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 8 weeks, progressive disease (PD) or NE. |
| Secondary | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression | Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 8 weeks |
| Secondary | Duration of Response (DoR) | RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression | Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment) |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF) | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Progression-Free Survival (PFS) | RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression | month | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression. | Participants | NUMBER | |
| SECONDARY | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression | Participants | NUMBER | |
| SECONDARY | Duration of Response (DoR) | RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression | Weeks | MEDIAN | |
| PRIMARY | Overall Survival (OS) | Time to death in months | Months | MEDIAN | |
| SECONDARY | Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF) | Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group12
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) | Vandetanib 300 mg | 1.9 | 95% Confidence Interval 1.84 to 2.23 | month | |
| Progression-Free Survival (PFS) | Placebo | 1.8 | 95% Confidence Interval 1.74 to 1.84 | month | |
| Objective Response Rate (ORR) | Vandetanib 300 mg | 16 | Participants | ||
| Objective Response Rate (ORR) | Placebo | 2 | Participants | ||
| Disease Control Rate (DCR) | Vandetanib 300 mg | 189 | Participants | ||
| Disease Control Rate (DCR) | Placebo | 48 | Participants | ||
| Duration of Response (DoR) | Vandetanib 300 mg | 23.9 | 95% Confidence Interval 16.57 to 27.00 | Weeks | |
| Duration of Response (DoR) | Placebo | 24.3 | 95% Confidence Interval 16.00 to 32.57 | Weeks | |
| Overall Survival (OS) | Vandetanib 300 mg | 8.5 | 95% Confidence Interval 7.81 to 9.76 | Months | |
| Overall Survival (OS) | Placebo | 7.8 | 95% Confidence Interval 6.08 to 9.17 | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib 300 mg | 617 | |
| Overall Study | STARTED | Placebo | 307 | |
| Overall Study | COMPLETED | Vandetanib 300 mg | 14 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Vandetanib 300 mg | 603 | |
| Overall Study | NOT COMPLETED | Placebo | 306 |
Source ClinicalTrials.gov
Adverse events362
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 | 19 | 619 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 19 | 303 | |
| other | Diarrhoea | Gastrointestinal disorders | Vandetanib | 284 | 619 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 34 | 303 | |
| other | Nausea | Gastrointestinal disorders | Vandetanib | 138 | 619 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 51 | 303 | |
| other | Constipation | Gastrointestinal disorders | Vandetanib | 88 | 619 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 63 | 303 | |
| other | Vomiting | Gastrointestinal disorders | Vandetanib | 82 | 619 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 36 | 303 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 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 | 557 | 619 |
| Total, other adverse events | Placebo | 234 | 303 |
| Total, serious adverse events | Vandetanib | 160 | 619 |
| Total, serious adverse events | Placebo | 63 | 303 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25881079 | DERIVED |
Source PubMed
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 300 mg vs Placebo: Disease Control Rate (DCR) | Trial comparisons |
| Vandetanib 300 mg vs Placebo: Objective Response Rate (ORR) | 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/NCT00404924
GET https://conductscience.org/api/trials/v1/NCT00404924/events?page=2