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CompletedNCT00617253Updated Mar 1, 2017

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

A Phase 2 interventional study of recombinant interleukin-21 and sunitinib in Cancer and Renal Cell Carcinoma, sponsored by Novo Nordisk A/S. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2007, registered Feb 2008).
Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
  • Renal Cell Carcinoma
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 9 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Browse Novo Nordisk A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    A

    Drug: recombinant interleukin-21 · Drug: sunitinib

  • Experimental
    B

    Drug: sunitinib · Drug: recombinant interleukin-21

  • Experimental
    C

    Drug: sunitinib · Drug: recombinant interleukin-21

  • Experimental
    D

    Drug: sunitinib · Drug: recombinant interleukin-21

Interventions

  • Drugrecombinant interleukin-21

    3 mcg/kg, s.c. injection

    Also known as: NN028, rIL-21

  • Drugsunitinib

    Hard gelatine capsules, 12.5 mg

    Also known as: Sutent®

  • Drugrecombinant interleukin-21

    10 mcg/kg, s.c. injection

    Also known as: NN028, rIL-21

  • Drugrecombinant interleukin-21

    30 mcg/kg, s.c. injection

    Also known as: NN028, rIL-21

  • Drugrecombinant interleukin-21

    100 mcg/kg, s.c. injection

    Also known as: NN028, rIL-21

06

What researchers measure

Primary outcomes

  1. Toxicity according to CTCAE version 3.0

    Time frame: For the duration of the trial

Secondary outcomes

  1. Pharmacokinetics

    Time frame: For the duration of the trial

  2. rIL-21 antibodies

    Time frame: For the duration of the trial

07

Study locations

5 sites
  • Novo Nordisk Investigational Site
    Frankfurt, 60488, Germany
  • Novo Nordisk Investigational Site
    Hamburg, 20246, Germany
  • Novo Nordisk Investigational Site
    Hanover, 30625, Germany
  • Novo Nordisk Investigational Site
    Amsterdam, 1066 CX, Netherlands
  • Novo Nordisk Investigational Site
    Nijmegen, 6525 GA, Netherlands
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2007 to primary completion in Jun 2008, 11 months.

Of 162 industry-sponsored phase 2 interventional studies under Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 72. This study's 11 months is below that.

Counting every sponsor, half of 554 studies reached it within 52 months; a quarter within 33 and three quarters within 88.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2008
First posted
Feb 15, 2008
StartActual
Jul 12, 2007
Primary completionActual
Jun 30, 2008
CompletionActual
Jun 30, 2008
Last update
Mar 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00617253
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 15, 2008
Start date
Jul 12, 2007
Primary completion
Jun 30, 2008
Completion
Jun 30, 2008
Last update
Mar 1, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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