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

February 28, 2017 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60488
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20246
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30625
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Novo Nordisk Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: recombinant interleukin-21
3 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: sunitinib
Hard gelatine capsules, 12.5 mg
Other Names:
  • Sutent®
Drug: recombinant interleukin-21
10 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
30 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
100 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Experimental: B
Drug: recombinant interleukin-21
3 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: sunitinib
Hard gelatine capsules, 12.5 mg
Other Names:
  • Sutent®
Drug: recombinant interleukin-21
10 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
30 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
100 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Experimental: C
Drug: recombinant interleukin-21
3 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: sunitinib
Hard gelatine capsules, 12.5 mg
Other Names:
  • Sutent®
Drug: recombinant interleukin-21
10 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
30 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
100 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Experimental: D
Drug: recombinant interleukin-21
3 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: sunitinib
Hard gelatine capsules, 12.5 mg
Other Names:
  • Sutent®
Drug: recombinant interleukin-21
10 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
30 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21
Drug: recombinant interleukin-21
100 mcg/kg, s.c. injection
Other Names:
  • NN028, rIL-21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity according to CTCAE version 3.0
Time Frame: For the duration of the trial
For the duration of the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: For the duration of the trial
For the duration of the trial
rIL-21 antibodies
Time Frame: For the duration of the trial
For the duration of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2007

Primary Completion (Actual)

June 30, 2008

Study Completion (Actual)

June 30, 2008

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN028-1642
  • 2006-005751-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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