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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00523380
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Cancer Ovarian Cancer Drug: recombinant interleukin-21 Drug: caelyx (pegylated liposomal doxorubicin) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2007
Actual Primary Completion Date : January 7, 2009
Actual Study Completion Date : January 7, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Doxorubicin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: recombinant interleukin-21
Administered i.v. in treatment cycles of 28 days.
Other Names:
  • rIL-21
  • NN028
Drug: caelyx (pegylated liposomal doxorubicin)
Administered i.v. in treatment cycles of 28 days.

Primary Outcome Measures :
  1. 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 Measures :
  1. Pharmacokinetics [ Time Frame: Initially ]
  2. IL-21 antibody formation [ Time Frame: For the duration of the trial ]
  3. Progression free survival [ Time Frame: For the duration of the trial ]
  4. Patient reported outcomes [ Time Frame: For the duration of the trial ]
  5. Biomarker assessments CA-125 [ Time Frame: For the duration of the trial ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00523380

Novo Nordisk Investigational Site
Lyon Cedex 08, France, 69373
Novo Nordisk Investigational Site
Marseille, France, 13273
Novo Nordisk Investigational Site
Saint-Herblain Cedex, France, 44805
Novo Nordisk Investigational Site
Villejuif, France, 94805
Novo Nordisk Investigational Site
Essen, Germany, 45122
Novo Nordisk Investigational Site
Marburg, Germany, 35043
Novo Nordisk Investigational Site
Wiesbaden, Germany, 65199
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00523380     History of Changes
Other Study ID Numbers: NN028-1802
2007-001506-25 ( EudraCT Number )
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action