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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2006-005023-42-GB |
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Date of registration:
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21/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A phase II, double-blind, placebo controlled, randomised study to assess the efficacy and safety of 2 doses of ZACTIMA (ZD6474) in combination with FOLFIRI vs. FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen
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Scientific title:
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A phase II, double-blind, placebo controlled, randomised study to assess the efficacy and safety of 2 doses of ZACTIMA (ZD6474) in combination with FOLFIRI vs. FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen |
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Date of first enrolment:
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16/05/2007 |
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Target sample size:
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96 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005023-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Have histologically confirmed colorectal cancer.
2. Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
· Progression on or following treatment for metastatic colorectal cancer
· Progression within 12 months of adjuvant chemotherapy for colorectal cancer.
3. Have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks.
4. Are suitable for treatment with irinotecan, 5-FU and leucovorin (FOLFIRI).
5. Be aged at least 18 years.
6. Provide written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
2. Previous adjuvant therapy with irinotecan within 12 months of randomisation.
3. More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.
4. Any recent surgery, unhealed surgical incision or severe concomitant condition which, in the Investigator’s opinion, makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the study protocol.
5. Current or prior malignancy within previous 3 years (other than colorectal cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix).
6. Brain metastases or spinal cord compression unless treated and stable off steroids for one month.
7. With the exception of alopecia and neuropathy, any unresolved toxicity = CTCAE grade 2 from previous anticancer therapy unless specified eleswhere within these selection criteria. Persistent neuropathy >CTCAE grade 2 following prior oxaliplatin therapy.
8. At time of randomisation less than 4 weeks since completion of prior radiotherapy to the primary tumour or persistence of any acute radiotherapy toxicity.
9. Chronic inflammatory bowel disease, bowel obstruction or other current active gastrointestinal disease.
10. Significant cardiovascular event (eg, myocardial infarction, New York Heart Association classification of heart disease (NYHA) = 2) within 3 months of randomisation, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
11. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, symptomatic or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication, is not excluded.
12. Left bundle branch block.
13. Hypertension not controlled by medical therapy (systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg).
14. Baseline mean QTc measurement =480ms using Bazett’s formula. Patients who are receiving a drug that has a risk of QTc prolongation (see Appendix C, Table 2) are excluded if QTc is =460ms.
15. Patients with factors that increase risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of unexplained sudden death under 40 years of age or any concomitant medication known to prolong QTc.
16. Any of the following laboratory values:
· Potassium < 4.0mmol/l despite supplementation
· Total calcium (or calcium adjusted for albumen) or magnesium below normal range despite supplementation.
17. Any of the following laboratory values:
· Total bilirubin > 1.5 x ULN (upper limit of normal)
· Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN if no demonstrable liver metastases or > 5 x ULN in presence of liver metastases.
18. Any
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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colorectal cancer
MedDRA version: 8.1
Level: LLT
Classification code 10061451
Term: Colorectal cancer
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Intervention(s)
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Product Name: ZACTIMA
Product Code: ZA6474
Pharmaceutical Form: Tablet
INN or Proposed INN: vandetanib
Current Sponsor code: ZD6474
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100mg-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: ZACTIMA
Product Code: ZA6474
Pharmaceutical Form: Tablet
INN or Proposed INN: vandetanib
Current Sponsor code: ZD6474
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300mg-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: irinotecan hydrochloride trihydrate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Product Name: leucovorin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: calcium folinate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Product Name: fluorouracil
Pharmaceutical Form: Solution for injection
INN or Proposed INN: fluorouracil
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
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Primary Outcome(s)
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Primary end point(s): The primary outcome variable is a progression event defined as the earliest of:
· Objective and/or clinical disease progression on or before data cut-off
· Death from any cause
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Main Objective: The primary objective of this study is to assess the efficacy of ZD6474 (100 mg and 300 mg) in combination with FOLFIRI versus FOLFIRI alone for the treatment of patients with colorectal cancer that have failed prior treatment with oxaliplatin and a fluoropyrimidine by assessment of disease progression.
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Secondary Objective: The secondary objectives of the study are to assess the safety and tolerability of ZD6474 (100 mg and 300 mg) in combination with FOLFIRI in the treatment of colorectal cancer by review of AEs and laboratory parameters.
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Secondary ID(s)
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D4200C00048
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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