Trial · NCT00508001
Phase II Study of Best Support Care (BSC) Plus ZD6474(Vandetanib) in Patients With Inoperable Hepatocellular Carcinoma (HCC)
NCT00508001, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2012-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Best Support Care (BSC) Plus ZD6474(Vandetanib) in Patients With Inoperable Hepatocellular Carcinoma (HCC). Trials, record NCT00508001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00508001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Best Support Care (BSC) Plus ZD6474(Vandetanib) in Patients With Inoperable Hepatocellular Carcinoma (HCC)
- NCT number
- NCT00508001
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Vandetanib, Vandetanib, Best Supportive Care
- First posted
- 2007-07-27
- Last updated
- 2016-10-10
- Results first posted
- 2012-07-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumour Stabilisation Rate | After 16 weeks of treatment. | Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for \>=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST). Complete Response - Disappearance of all target lesions; Partial Response - \>=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - \>=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Objective Response Rate | After 16 weeks of treatment. | Objective Response rate defined as percentage of patients with Complete Response \[CR\] or Partial Response \[PR\] based on Response Evaluation Criteria in Solid Tumours (RECIST). Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions as assessed by Magnetic Resonance Imaging (MRI). Complete response (CR) must have disappearance of all target and non-target lesions as assessed by MRI. |
| Secondary | Progression-free Survival | from the date of randomisation to the date of documented disease progression or death for any cause | Progression-free survival defined as the period from date of randomization(start of treatment) to date of disease progression or death. |
| Secondary | Overall Survival | assessed up to 360 days | Overall survival defined as the time from randomization (start of treatment) until death from any cause. |
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 | Tumour Stabilisation Rate | After 16 weeks of treatment. | The analysis has been performed in the Intent-To-Treat (ITT) population. | percentage of patients | NUMBER |
| SECONDARY | Objective Response Rate | After 16 weeks of treatment. | The analysis has been performed in the Intent-To-Treat (ITT) population. | percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival | from the date of randomisation to the date of documented disease progression or death for any cause | The analysis has been performed in the Intent-To-Treat (ITT) population. | Days | MEAN |
| SECONDARY | Overall Survival | assessed up to 360 days | The analysis performed in the intent-To-Treat population. | Days | 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 |
|---|---|---|---|---|---|
| Tumour Stabilisation Rate | ZD6474 300 | 5.3 | percentage of patients | ||
| Tumour Stabilisation Rate | ZD6474 100 | 16.0 | percentage of patients | ||
| Tumour Stabilisation Rate | Placebo | 8.7 | percentage of patients | ||
| Objective Response Rate | ZD6474 300 | 0 | percentage of patients | ||
| Objective Response Rate | ZD6474 100 | 0 | percentage of patients | ||
| Objective Response Rate | Placebo | 0 | percentage of patients | ||
| Progression-free Survival | ZD6474 300 | 32 | 95% Confidence Interval 29 | Days | |
| Progression-free Survival | ZD6474 100 | 53 | 95% Confidence Interval 29 | Days | |
| Progression-free Survival | Placebo | 29 | 95% Confidence Interval 28 | Days | |
| Overall Survival | ZD6474 300 | 181 | 95% Confidence Interval 117 to 290 | Days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZD6474 300 | 19 | |
| Overall Study | STARTED | ZD6474 100 | 25 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | Secondary Treatment Phase | ZD6474 300 | 0 | |
| Overall Study | Secondary Treatment Phase | ZD6474 100 | 13 | |
| Overall Study | Secondary Treatment Phase | Placebo | 16 | |
| Overall Study | COMPLETED | ZD6474 300 | 0 | |
| Overall Study | COMPLETED | ZD6474 100 | 13 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | ZD6474 300 | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events288
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 | ZD6474 300 | 0 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | ZD6474 100 | 0 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 23 | |
| other | Deficiency Anaemia | Blood and lymphatic system disorders | ZD6474 300 | 1 | 19 | |
| other | Deficiency Anaemia | Blood and lymphatic system disorders | ZD6474 100 | 0 | 25 | |
| other | Deficiency Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 23 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ZD6474 300 | 1 | 19 | |
| other | Leukocytosis | Blood and lymphatic system disorders | ZD6474 100 | 1 | 25 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 1 | 23 | |
| other | Tachycardia | Cardiac disorders | ZD6474 300 | 1 | 19 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZD6474 300 | ||
| Total, all-cause mortality | ZD6474 100 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ZD6474 300 | 18 | 19 |
| Total, other adverse events | ZD6474 100 | 24 | 25 |
| Total, other adverse events | Placebo | 21 | 23 |
| Total, serious adverse events | ZD6474 300 | 6 | 19 |
| Total, serious adverse events | ZD6474 100 | 4 | 25 |
| Total, serious adverse events | Placebo | 4 | 23 |
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 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/NCT00508001
GET https://conductscience.org/api/trials/v1/NCT00508001/events?page=2