Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
Phase 2
Completed
- Conditions
- CancerRenal Cell Carcinoma
- Interventions
- Drug: recombinant interleukin-21
- Registration Number
- NCT00617253
- Lead Sponsor
- Novo Nordisk A/S
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A recombinant interleukin-21 - D recombinant interleukin-21 - B recombinant interleukin-21 - C recombinant interleukin-21 - D sunitinib - C sunitinib - A sunitinib - B sunitinib -
- Primary Outcome Measures
Name Time Method Toxicity according to CTCAE version 3.0 For the duration of the trial
- Secondary Outcome Measures
Name Time Method Pharmacokinetics For the duration of the trial rIL-21 antibodies For the duration of the trial
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇳🇱Nijmegen, Netherlands