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Efficacy of Recombinant Interleukin-21 in Patients With Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Cancer

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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

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