Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
February 28, 2017 updated by: Novo Nordisk A/S
An Open Label, Dose Escalation Safety and Tolerability Trial of the Combination of s.c. Recombinant Human IL-21 (rIL-21) and Sunitinib (Phase 1) Followed by an Open Label Stratified Randomized 2-arm Trial of rIL-21 Plus Sunitinib Versus Sunitinib Alone (Phase 2a) in Subjects With Stage IV Renal Cell Carcinoma
This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt, Germany, 60488
- Novo Nordisk Investigational Site
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Hamburg, Germany, 20246
- Novo Nordisk Investigational Site
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Hannover, Germany, 30625
- Novo Nordisk Investigational Site
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-
-
-
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Amsterdam, Netherlands, 1066 CX
- Novo Nordisk Investigational Site
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Nijmegen, Netherlands, 6525 GA
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically verified and surgically incurable stage IV Renal Cell Carcinoma
- ECOG performance status of 0 or 1 (i.e. good performance status)
- Life expectancy of at least 3 months
Exclusion Criteria:
- Prior systemic therapy for metastatic disease
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
|
3 mcg/kg, s.c. injection
Other Names:
Hard gelatine capsules, 12.5 mg
Other Names:
10 mcg/kg, s.c. injection
Other Names:
30 mcg/kg, s.c. injection
Other Names:
100 mcg/kg, s.c. injection
Other Names:
|
|
Experimental: B
|
3 mcg/kg, s.c. injection
Other Names:
Hard gelatine capsules, 12.5 mg
Other Names:
10 mcg/kg, s.c. injection
Other Names:
30 mcg/kg, s.c. injection
Other Names:
100 mcg/kg, s.c. injection
Other Names:
|
|
Experimental: C
|
3 mcg/kg, s.c. injection
Other Names:
Hard gelatine capsules, 12.5 mg
Other Names:
10 mcg/kg, s.c. injection
Other Names:
30 mcg/kg, s.c. injection
Other Names:
100 mcg/kg, s.c. injection
Other Names:
|
|
Experimental: D
|
3 mcg/kg, s.c. injection
Other Names:
Hard gelatine capsules, 12.5 mg
Other Names:
10 mcg/kg, s.c. injection
Other Names:
30 mcg/kg, s.c. injection
Other Names:
100 mcg/kg, s.c. injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Toxicity according to CTCAE version 3.0
Time Frame: For the duration of the trial
|
For the duration of the trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics
Time Frame: For the duration of the trial
|
For the duration of the trial
|
|
rIL-21 antibodies
Time Frame: For the duration of the trial
|
For the duration of the trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2007
Primary Completion (Actual)
June 30, 2008
Study Completion (Actual)
June 30, 2008
Study Registration Dates
First Submitted
February 4, 2008
First Submitted That Met QC Criteria
February 4, 2008
First Posted (Estimate)
February 15, 2008
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- NN028-1642
- 2006-005751-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.