Trial · NCT00496509
Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer
NCT00496509, Phase 1, Completed, Genzyme, a Sanofi Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer. Trials, record NCT00496509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496509
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer
- NCT number
- NCT00496509
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Colorectal Cancer
- Interventions
- ZD6474 (Zactima) 100mg, Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR), Biomarker Draws, ZD6474 (Zactima) 300mg
- First posted
- 2007-07-04
- Last updated
- 2016-08-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess by dynamic contrast-enhanced magnetic resonance imaging the effect of once daily dosing with ZD6474 on tumour perfusion and vascular permeability in patients with advanced colorectal cancer and liver metastases. | Up to 57 days. | |
| Secondary | Assessment of appropriate Pharmacokinetic parameters | Predetermined timepoints after dose administration | The exposure to ZD6474 in patients with advanced colorectal cancer and liver metastases by assessment of: maximum plasma concentration after single and at steady state (C max and Css, max); time to reach C max and Css, max (tmax); minimum plasma concentration before and at steady state (Cmin and Css, min); area under plasma concentration-time curve from zero to 24 h and at steady state (AUC(0-24) and AUCss); total body clearance of drug from plasma after an oral dose (CL/F): accumulation ratio (Rac) and fraction of ZD6474 unbound (fu). |
| Secondary | Determine the population PK of ZD6474 and assess the relationship between both free and total plasma PK and measures of Pharmacological activity | Predetermined timepoints after dose administration | Determination of the population PK of ZD6474 and the assessment of the relationship between both free and total plasma PK and measures of pharmacological activity by assessment of individual predicted plasma concentrations, individual predicted CL/F, AUCss, Css, max, and AUC to the point up to the scan. |
| Secondary | Assessment of the effectiveness of ZD6474 as measured by objective response rate and progression free survival based on RECIST. | Every 8 weeks during the study |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19946413 | BACKGROUND |
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 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/NCT00496509
GET https://conductscience.org/api/trials/v1/NCT00496509/registered