Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Renal Cell Carcinoma

Intervention / Treatment
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* Drug: recombinant interleukin-21
* Drug: sunitinib
* Drug: recombinant interleukin-21
* Drug: recombinant interleukin-21
* Drug: recombinant interleukin-21


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: recombinant interleukin-21<br>* 3 mcg/kg, s.c. injection<br>* Other names: NN028, rIL-21;Drug: sunitinib<br>* Hard gelatine capsules, 12.5 mg<br>* Other names: Sutent®;|
| Experimental: B<br> | Drug: sunitinib<br>* Hard gelatine capsules, 12.5 mg<br>* Other names: Sutent®;Drug: recombinant interleukin-21<br>* 10 mcg/kg, s.c. injection<br>* Other names: NN028, rIL-21;|
| Experimental: C<br> | Drug: sunitinib<br>* Hard gelatine capsules, 12.5 mg<br>* Other names: Sutent®;Drug: recombinant interleukin-21<br>* 30 mcg/kg, s.c. injection<br>* Other names: NN028, rIL-21;|
| Experimental: D<br> | Drug: sunitinib<br>* Hard gelatine capsules, 12.5 mg<br>* Other names: Sutent®;Drug: recombinant interleukin-21<br>* 100 mcg/kg, s.c. injection<br>* Other names: NN028, rIL-21;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity according to CTCAE version 3.0 |  | For the duration of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | For the duration of the trial | 
| rIL-21 antibodies |  | For the duration of the trial |