NCT00617253|CompletedPhase 2

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN028-16422006-005751-16

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredFeb 2008

StartedJul 2007

CompletionJun 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 cancer

Timeline

Completed

Started Jul 2007

Shorter than P25 for phase_2 cancer

Geographic Reach

2 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

Study Start

First participant enrolled

July 12, 2007

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed

11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2008

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

February 4, 2008

Last Update Submit

February 28, 2017

Conditions

Cancer Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

Toxicity according to CTCAE version 3.0
For the duration of the trial

Secondary Outcomes (2)

Pharmacokinetics
For the duration of the trial
rIL-21 antibodies
For the duration of the trial

Study Arms (4)

A

EXPERIMENTAL

Drug: recombinant interleukin-21Drug: sunitinib

B

EXPERIMENTAL

Drug: sunitinibDrug: recombinant interleukin-21

C

EXPERIMENTAL

Drug: sunitinibDrug: recombinant interleukin-21

D

EXPERIMENTAL

Drug: sunitinibDrug: recombinant interleukin-21

Interventions

recombinant interleukin-21DRUG

3 mcg/kg, s.c. injection

Also known as: NN028, rIL-21

sunitinibDRUG

Hard gelatine capsules, 12.5 mg

Also known as: Sutent®

ABCD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.