Phase I Efficacy On Vascular Permeability In Patients With Advanced Colorectal Cancer
A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability In Patients With Advanced Colorectal Cancer and Liver Metastases
1 other identifier
interventional
24
1 country
1
Brief Summary
A Phase I, Open-Label Study To Assess The Effect of ZD6474 (ZACTIMA) On Vascular Permeability In Patients with Advanced Colorectal Cancer and Liver Metastases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 colorectal-cancer
Started Aug 2006
Shorter than P25 for phase_1 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 3, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedAugust 26, 2016
August 1, 2016
1.2 years
July 3, 2007
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Assessment of appropriate Pharmacokinetic parameters
Predetermined timepoints after dose administration
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
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
Study Arms (2)
ZD6474 (vandetanib) 100mg
EXPERIMENTALZD6474 (vandetanib) 300mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic colorectal adenocarcinoma (stage IV) with at least 1 measurable hepatic lesion of 20 mm or more on MRI and for whom no standard therapy is available.
- WHO Performance status 0 - 2.
- Life expectancy of at least 12 weeks
You may not qualify if:
- Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry and stable without steroid treatment for 10 days or greater.
- Last dose of prior chemotherapy must be discontinued at least 4 weeks before the start of study treatment.
- Last dose of radiotherapy received within 4 weeks before the start of study treatment excluding palliative radiotherapy.
- Prior treatment with VEGFR TKIs
- Serum bilirubin . 1.5 x the upper limit of reference range.
- Serum creatinine \>1.5 x ULRR or Creatinine clearance (as determined by the Cockcroft - Gault method) less than or equal to 50 mL/min.
- ALT or AST \>5 x ULRR
- ALP \>5 x ULRR
- Evidence of severe or uncontrolled systemic disease or any concurrent conditions which in the investigators opinion make it undesirable for the patient to participate in the study or would jeopardize compliance with the protocol.
- Any unresolved toxicity greater than CTCAE Grade 2 for previous anti-cancer therapy.
- Significant cardiovascular event within 3 months before entry, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia.
- History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled by medication is not excluded.
- Congenital long QT syndrome or 1st degree relative with sudden unexplained death under of 40 years of age.
- Presence of Left Bundle Branch Block.
- QTc with Bazett's correction unmeasurable or greater than or equal to 480 msec or greater of screening ECG.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Site
Freiberg, Germany
Related Publications (1)
Mross K, Fasol U, Frost A, Benkelmann R, Kuhlmann J, Buchert M, Unger C, Blum H, Hennig J, Milenkova TP, Tessier J, Krebs AD, Ryan AJ, Fischer R. DCE-MRI assessment of the effect of vandetanib on tumor vasculature in patients with advanced colorectal cancer and liver metastases: a randomized phase I study. J Angiogenes Res. 2009 Sep 21;1:5. doi: 10.1186/2040-2384-1-5.
PMID: 19946413BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2007
First Posted
July 4, 2007
Study Start
August 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
August 26, 2016
Record last verified: 2016-08