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NCT00617253 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00617253
Other study ID # NN028-1642
Secondary ID 2006-005751-16
Status Completed
Phase Phase 2
First received February 4, 2008
Last updated February 28, 2017
Start date July 12, 2007
Est. completion date June 30, 2008

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date June 30, 2008
Est. primary completion date June 30, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Frankfurt
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hannover
Netherlands Novo Nordisk Investigational Site Amsterdam
Netherlands Novo Nordisk Investigational Site Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Toxicity according to CTCAE version 3.0 For the duration of the trial
Secondary Pharmacokinetics For the duration of the trial
Secondary rIL-21 antibodies For the duration of the trial
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