CancerPhase 2NCT00523380
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
A Phase 2 study testing recombinant interleukin-21 and caelyx (pegylated liposomal doxorubicin) in people with Cancer and Ovarian Cancer, run by Novo Nordisk A/S at 7 sites in 2 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Ovarian Cancer
- What is being tested?
- recombinant interleukin-21 and caelyx (pegylated liposomal doxorubicin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 4 Oct 2007to 7 Jan 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced epithelial Ovarian Cancer (stage IIB-IV)
- Persistent or progressive disease after or relapse within one year of completion of first line therapy
- Measurable or assessable disease
- Eastern Cooperative Oncology Group status less than or equal to 2
Who cannot join
- History of any other active malignancy
- Signs of CNS metastasis
- More than one prior chemotherapy regimen
- Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks
- First line chemotherapy completed at least 1 month prior to start of treatment
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France4 sites
Novo Nordisk Investigational Site
Lyon, 69373
Novo Nordisk Investigational Site
Marseille, 13273
Novo Nordisk Investigational Site
Saint-Herblain, 44805
Novo Nordisk Investigational Site
Villejuif, 94805
Germany3 sites
Novo Nordisk Investigational Site
Essen, 45122
Novo Nordisk Investigational Site
Marburg, 35043
Novo Nordisk Investigational Site
Wiesbaden, 65199
About this study
Official title: An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.
- Conditions
- Cancer, Ovarian Cancer
- Being tested
- recombinant interleukin-21, caelyx (pegylated liposomal doxorubicin)
- Medical subject headings
- Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interleukin-21Drug
Also called rIL-21, NN028
Administered i.v. in treatment cycles of 28 days.
caelyx (pegylated liposomal doxorubicin)Drug
Administered i.v. in treatment cycles of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: recombinant interleukin-21; Drug: caelyx (pegylated liposomal doxorubicin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
Measured: after max. 6 treatment cycles
Secondary outcomes (5)
Pharmacokinetics
Measured: Initially
IL-21 antibody formation
Measured: For the duration of the trial
Progression free survival
Measured: For the duration of the trial
Patient reported outcomes
Measured: For the duration of the trial
Biomarker assessments CA-125
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 posted31 Aug 2007 (estimated)
- Study start4 Oct 2007
- Primary completion7 Jan 2009
- Study completion7 Jan 2009
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
- 10 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
- NCT00523380
- Sponsor's protocol ID
- NN028-1802
- Other IDs
- 2007-001506-25
- Status last verified
- Feb 2017
- First submitted
- 30 Aug 2007
- 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 Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy
- ClinicalTrials.gov ID
- NCT00523380
- Acronym / sponsor ID
- NN028-1802
- Conditions
- Cancer, Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2007 (actual)
- Primary completion
- 7 Jan 2009 (actual)
- Study completion
- 7 Jan 2009 (actual)
- First posted
- 31 Aug 2007 (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 trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: recombinant interleukin-21, Drug: caelyx (pegylated liposomal doxorubicin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced epithelial Ovarian Cancer (stage IIB-IV)
- Persistent or progressive disease after or relapse within one year of completion of first line therapy
- Measurable or assessable disease
- Eastern Cooperative Oncology Group status less than or equal to 2
Key exclusion criteria (5 listed)
- History of any other active malignancy
- Signs of CNS metastasis
- More than one prior chemotherapy regimen
- Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks
- First line chemotherapy completed at least 1 month prior to start of treatment
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: rIL-21, NN028Administered i.v. in treatment cycles of 28 days. | Drug | A |
| caelyx (pegylated liposomal doxorubicin)Administered i.v. in treatment cycles of 28 days. | Drug | A |
Primary outcome
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
Time frame: after max. 6 treatment cycles
5 secondary outcomes
Pharmacokinetics
Time frame: Initially
IL-21 antibody formation
Time frame: For the duration of the trial
Progression free survival
Time frame: For the duration of the trial
Patient reported outcomes
Time frame: For the duration of the trial
Biomarker assessments CA-125
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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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
7 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 caelyx (pegylated liposomal doxorubicin) in people with Cancer and Ovarian Cancer, run by Novo Nordisk A/S at 7 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 4 inclusion and 5 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 7 sites in France, Germany. 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?
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination. (time frame: after max. 6 treatment cycles). 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.