Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Cancer

Renal Cell Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 sunit...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 12 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2008

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT00617253

Start Date

July 12 2007

End Date

June 30 2008

Last Update

March 1 2017

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Novo Nordisk Investigational Site

Frankfurt, Germany, 60488

2

Novo Nordisk Investigational Site

Hamburg, Germany, 20246

3

Novo Nordisk Investigational Site

Hanover, Germany, 30625

4

Novo Nordisk Investigational Site

Amsterdam, Netherlands, 1066 CX