Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
NCT ID: NCT00617253
Last Updated: 2017-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2007-07-12
2008-06-30
Brief Summary
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The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
recombinant interleukin-21
3 mcg/kg, s.c. injection
sunitinib
Hard gelatine capsules, 12.5 mg
B
sunitinib
Hard gelatine capsules, 12.5 mg
recombinant interleukin-21
10 mcg/kg, s.c. injection
C
sunitinib
Hard gelatine capsules, 12.5 mg
recombinant interleukin-21
30 mcg/kg, s.c. injection
D
sunitinib
Hard gelatine capsules, 12.5 mg
recombinant interleukin-21
100 mcg/kg, s.c. injection
Interventions
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recombinant interleukin-21
3 mcg/kg, s.c. injection
sunitinib
Hard gelatine capsules, 12.5 mg
recombinant interleukin-21
10 mcg/kg, s.c. injection
recombinant interleukin-21
30 mcg/kg, s.c. injection
recombinant interleukin-21
100 mcg/kg, s.c. injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status of 0 or 1 (i.e. good performance status)
* Life expectancy of at least 3 months
Exclusion Criteria
* Radiotherapy within the last 4 weeks prior to start of treatment
* Receipt of any investigational drug within 3 months of starting treatment
* History of any other active malignancy within five years prior to enrolment
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Frankfurt, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hanover, , Germany
Novo Nordisk Investigational Site
Amsterdam, , Netherlands
Novo Nordisk Investigational Site
Nijmegen, , Netherlands
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-005751-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN028-1642
Identifier Type: -
Identifier Source: org_study_id
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