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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Toxicity according to CTCAE version 3.0
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A
Intervention: recombinant interleukin-21 (Drug)
D
Intervention: recombinant interleukin-21 (Drug)
B
Intervention: recombinant interleukin-21 (Drug)
C
Intervention: recombinant interleukin-21 (Drug)
A
Intervention: sunitinib (Drug)
C
Intervention: sunitinib (Drug)
B
Intervention: sunitinib (Drug)
D
Intervention: sunitinib (Drug)
Outcomes
Primary Outcomes
Toxicity according to CTCAE version 3.0
Time Frame: For the duration of the trial
Secondary Outcomes
- rIL-21 antibodies(For the duration of the trial)
- Pharmacokinetics(For the duration of the trial)