Cancer, Renal Cell Carcinoma
Conditions
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.
Interventions
3 mcg/kg, s.c. injection
DRUGsunitinib
Hard gelatine capsules, 12.5 mg
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity according to CTCAE version 3.0 | For the duration of the trial |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | For the duration of the trial |
| rIL-21 antibodies | For the duration of the trial |
Countries
Germany, Netherlands
Outcome results
None listed