Back to resultsEfficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
Primary Purpose
Cancer, Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
recombinant interleukin-21
caelyx (pegylated liposomal doxorubicin)
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
Secondary Outcome Measures
Pharmacokinetics
IL-21 antibody formation
Progression free survival
Patient reported outcomes
Biomarker assessments CA-125
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523380
Brief Title
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2007 (Actual)
Primary Completion Date
January 7, 2009 (Actual)
Study Completion Date
January 7, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
recombinant interleukin-21
Other Intervention Name(s)
rIL-21, NN028
Intervention Description
Administered i.v. in treatment cycles of 28 days.
Intervention Type
Drug
Intervention Name(s)
caelyx (pegylated liposomal doxorubicin)
Intervention Description
Administered i.v. in treatment cycles of 28 days.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
Initially
Title
IL-21 antibody formation
Time Frame
For the duration of the trial
Title
Progression free survival
Time Frame
For the duration of the trial
Title
Patient reported outcomes
Time Frame
For the duration of the trial
Title
Biomarker assessments CA-125
Time Frame
For the duration of the trial
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint-Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
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