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

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ClinicalTrials.gov Identifier: NCT00617253
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cancer Renal Cell Carcinoma Drug: recombinant interleukin-21 Drug: sunitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 12, 2007
Actual Primary Completion Date : June 30, 2008
Actual Study Completion Date : June 30, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Toxicity according to CTCAE version 3.0 [ Time Frame: For the duration of the trial ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: For the duration of the trial ]
  2. rIL-21 antibodies [ Time Frame: For the duration of the trial ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617253


Locations
Germany
Novo Nordisk Investigational Site
Frankfurt, Germany, 60488
Novo Nordisk Investigational Site
Hamburg, Germany, 20246
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Netherlands
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1066 CX
Novo Nordisk Investigational Site
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00617253     History of Changes
Other Study ID Numbers: NN028-1642
2006-005751-16 ( EudraCT Number )
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors