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NCT00523380 Clinical Trial

Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00523380
Other study ID # NN028-1802
Secondary ID 2007-001506-25
Status Completed
Phase Phase 2
First received August 30, 2007
Last updated February 28, 2017
Start date October 4, 2007
Est. completion date January 7, 2009

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 7, 2009
Est. primary completion date January 7, 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant interleukin-21
Administered i.v. in treatment cycles of 28 days.
• caelyx (pegylated liposomal doxorubicin)
Administered i.v. in treatment cycles of 28 days.

Locations
Country Name City State
France Novo Nordisk Investigational Site Lyon Cedex 08
France Novo Nordisk Investigational Site Marseille
France Novo Nordisk Investigational Site Saint-Herblain Cedex
France Novo Nordisk Investigational Site Villejuif
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Marburg
Germany Novo Nordisk Investigational Site Wiesbaden

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination. after max. 6 treatment cycles
Secondary Pharmacokinetics Initially
Secondary IL-21 antibody formation For the duration of the trial
Secondary Progression free survival For the duration of the trial
Secondary Patient reported outcomes For the duration of the trial
Secondary Biomarker assessments CA-125 For the duration of the trial
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