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

NCT00617253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-03-01

No results posted yet for this 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.

Conditions

Interventions

DRUG

recombinant interleukin-21

3 mcg/kg, s.c. injection

DRUG

sunitinib

Hard gelatine capsules, 12.5 mg

DRUG

recombinant interleukin-21

10 mcg/kg, s.c. injection

DRUG

recombinant interleukin-21

30 mcg/kg, s.c. injection

DRUG

recombinant interleukin-21

100 mcg/kg, s.c. injection

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-12
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Germany
  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617253 on ClinicalTrials.gov