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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005751-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant interleukin-21 | Drug | 3 mcg/kg, s.c. injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity according to CTCAE version 3.0 | For the duration of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | For the duration of the trial | |
| rIL-21 antibodies | For the duration of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Frankfurt | 60488 | Germany | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| sunitinib | Drug | Hard gelatine capsules, 12.5 mg |
|
|
| recombinant interleukin-21 | Drug | 10 mcg/kg, s.c. injection |
|
|
| recombinant interleukin-21 | Drug | 30 mcg/kg, s.c. injection |
|
|
| recombinant interleukin-21 | Drug | 100 mcg/kg, s.c. injection |
|
|
| Hamburg |
| 20246 |
| Germany |
| Novo Nordisk Investigational Site | Hanover | 30625 | Germany |
| Novo Nordisk Investigational Site | Amsterdam | 1066 CX | Netherlands |
| Novo Nordisk Investigational Site | Nijmegen | 6525 GA | Netherlands |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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