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

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Cancer

Renal Cell Carcinoma

Treatments

Drug: sunitinib

Drug: recombinant interleukin-21

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617253

NN028-1642

2006-005751-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 4 patient groups

A

Experimental group

Treatment:

Drug: recombinant interleukin-21

Drug: sunitinib

B

Experimental group

Treatment:

Drug: recombinant interleukin-21

Drug: sunitinib

C

Experimental group

Treatment:

Drug: recombinant interleukin-21

Drug: sunitinib

D

Experimental group

Treatment:

Drug: recombinant interleukin-21

Drug: sunitinib

Trial contacts and locations

5

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