CancerPhase 2NCT00617253
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
A Phase 2 study testing recombinant interleukin-21 and sunitinib in people with Cancer and Renal Cell Carcinoma, run by Novo Nordisk A/S at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Renal Cell Carcinoma
- What is being tested?
- recombinant interleukin-21 and sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Jul 2007to 30 Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Novo Nordisk Investigational Site
Frankfurt, 60488
Novo Nordisk Investigational Site
Hamburg, 20246
Novo Nordisk Investigational Site
Hanover, 30625
Netherlands2 sites
Novo Nordisk Investigational Site
Amsterdam, 1066 CX
Novo Nordisk Investigational Site
Nijmegen, 6525 GA
About this study
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
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
- Cancer, Renal Cell Carcinoma
- Being tested
- recombinant interleukin-21, sunitinib
- Medical subject headings
- Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interleukin-21Drug
Also called NN028, rIL-21
3 mcg/kg, s.c. injection
sunitinibDrug
Also called Sutent®
Hard gelatine capsules, 12.5 mg
recombinant interleukin-21Drug
Also called NN028, rIL-21
10 mcg/kg, s.c. injection
recombinant interleukin-21Drug
Also called NN028, rIL-21
30 mcg/kg, s.c. injection
recombinant interleukin-21Drug
Also called NN028, rIL-21
100 mcg/kg, s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: recombinant interleukin-21; Drug: sunitinib |
| B | Experimental | Not described Receives: Drug: sunitinib; Drug: recombinant interleukin-21 |
| C | Experimental | Not described Receives: Drug: sunitinib; Drug: recombinant interleukin-21 |
| D | Experimental | Not described Receives: Drug: sunitinib; Drug: recombinant interleukin-21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity according to CTCAE version 3.0
Measured: For the duration of the trial
Secondary outcomes (2)
Pharmacokinetics
Measured: For the duration of the trial
rIL-21 antibodies
Measured: For the duration of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study start12 Jul 2007
- Primary completion30 Jun 2008
- Study completion30 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617253
- Sponsor's protocol ID
- NN028-1642
- Other IDs
- 2006-005751-16
- Status last verified
- Feb 2017
- First submitted
- 4 Feb 2008
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00617253
- Acronym / sponsor ID
- NN028-1642
- Conditions
- Cancer, Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2007 (actual)
- Primary completion
- 30 Jun 2008 (actual)
- Study completion
- 30 Jun 2008 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: recombinant interleukin-21, Drug: sunitinib |
| B | Experimental | Drug: sunitinib, Drug: recombinant interleukin-21 |
| C | Experimental | Drug: sunitinib, Drug: recombinant interleukin-21 |
| D | Experimental | Drug: sunitinib, Drug: recombinant interleukin-21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interleukin-21Also: NN028, rIL-213 mcg/kg, s.c. injection | Drug | A |
| sunitinibAlso: Sutent®Hard gelatine capsules, 12.5 mg | Drug | A, B, C, D |
| recombinant interleukin-21Also: NN028, rIL-2110 mcg/kg, s.c. injection | Drug | B |
| recombinant interleukin-21Also: NN028, rIL-2130 mcg/kg, s.c. injection | Drug | C |
| recombinant interleukin-21Also: NN028, rIL-21100 mcg/kg, s.c. injection | Drug | D |
Primary outcome
Toxicity according to CTCAE version 3.0
Time frame: For the duration of the trial
2 secondary outcomes
Pharmacokinetics
Time frame: For the duration of the trial
rIL-21 antibodies
Time frame: For the duration of the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interleukin-21 and sunitinib in people with Cancer and Renal Cell Carcinoma, run by Novo Nordisk A/S at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity according to CTCAE version 3.0 (time frame: For the duration of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.