Trial Information
Efficacy of Recombinant Interleukin-21 in Patients With Ovarian Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Time Frame:
after max. 6 treatment cycles
Safety Issue:
No
Principal Investigator
Paul Kristjansen
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
NN028-1802
NCT ID:
NCT00523380
Start Date:
October 2007
Completion Date:
January 2009
Related Keywords:
- Ovarian Cancer
- Cancer
- Ovarian Neoplasms