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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00617253

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 I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Interleukin-21 Sunitinib malate Sunitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	Phase 1: Dose Escalation Safety Trial of the Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib. Phase 2a: Randomised 2-Arm Efficacy Trial Comparing rIL-21 Plus Sunitinib With Sunitinib Alone.

Further study details as provided by Novo Nordisk:

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
A: Experimental	Drug: recombinant interleukin-21 3 mcg/kg, s.c. injection Drug: sunitinib Hard gelatine capsules, 12.5 mg
B: Experimental	Drug: sunitinib Hard gelatine capsules, 12.5 mg Drug: recombinant interleukin-21 10 mcg/kg, s.c. injection
C: Experimental	Drug: sunitinib Hard gelatine capsules, 12.5 mg Drug: recombinant interleukin-21 30 mcg/kg, s.c. injection
D: Experimental	Drug: sunitinib Hard gelatine capsules, 12.5 mg Drug: recombinant interleukin-21 100 mcg/kg, s.c. injection

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

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

Investigators

Study Director:

Paul Kristjansen, MD, PhD, DMSc

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN028-1642, EudraCT No: 2006-005751-16
Study First Received:	February 4, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00617253 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Carcinoma
Renal Cancer

Urologic Diseases
Kidney Neoplasms
Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009