Back to resultsCombination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
Primary Purpose
Cancer, Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
recombinant interleukin-21
sunitinib
recombinant interleukin-21
recombinant interleukin-21
recombinant interleukin-21
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
Arm Description
Outcomes
Primary Outcome Measures
Toxicity according to CTCAE version 3.0
Secondary Outcome Measures
Pharmacokinetics
rIL-21 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00617253
Brief Title
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 12, 2007 (Actual)
Primary Completion Date
June 30, 2008 (Actual)
Study Completion Date
June 30, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Other Intervention Name(s)
NN028, rIL-21
Intervention Description
3 mcg/kg, s.c. injection
Intervention Type
Drug
Intervention Name(s)
sunitinib
Other Intervention Name(s)
Sutent®
Intervention Description
Hard gelatine capsules, 12.5 mg
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Other Intervention Name(s)
NN028, rIL-21
Intervention Description
10 mcg/kg, s.c. injection
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Other Intervention Name(s)
NN028, rIL-21
Intervention Description
30 mcg/kg, s.c. injection
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Other Intervention Name(s)
NN028, rIL-21
Intervention Description
100 mcg/kg, s.c. injection
Primary Outcome Measure Information:
Title
Toxicity according to CTCAE version 3.0
Time Frame
For the duration of the trial
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
For the duration of the trial
Title
rIL-21 antibodies
Time Frame
For the duration of the trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
We'll reach out to this number within 24 hrs