Phase 1: Dose Escalation Safety Trial of the Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib. Phase 2a: Randomised 2-arm Efficacy Trial Comparing rIL-21 Plus Sunitinib With Sunitinib Alone.
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer, Renal Cell Carcinoma
Both
Cancer, Renal Cell Carcinoma
Trial Information
Phase 1: Dose Escalation Safety Trial of the Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib. Phase 2a: Randomised 2-arm Efficacy Trial Comparing rIL-21 Plus Sunitinib With Sunitinib Alone.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity according to CTCAE version 3.0
Outcome Time Frame:
For the duration of the trial
Safety Issue:
No
Principal Investigator
Paul Kristjansen, MD, PhD, DMSc
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
NN028-1642
NCT ID:
NCT00617253
Start Date:
July 2007
Completion Date:
June 2008
Related Keywords:
- Cancer
- Renal Cell Carcinoma
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|
