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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00617253
First received: February 4, 2008
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Cancer
Renal Cell Carcinoma
Drug: recombinant interleukin-21
Drug: sunitinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Toxicity according to CTCAE version 3.0 [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • rIL-21 antibodies [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617253

Locations
Germany
Hamburg, Germany, 20246
Netherlands
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Paul Kristjansen, MD, PhD, DMSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00617253     History of Changes
Other Study ID Numbers: NN028-1642, 2006-005751-16
Study First Received: February 4, 2008
Last Updated: October 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on October 22, 2014