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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00523380
First received: August 30, 2007
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Cancer
Ovarian Cancer
Drug: recombinant interleukin-21
Drug: caelyx (pegylated liposomal doxorubicin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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. [ Time Frame: after max. 6 treatment cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Initially ] [ Designated as safety issue: No ]
  • IL-21 antibody formation [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Biomarker assessments CA-125 [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523380

Locations
France
Lyon Cedex 08, France, 69373
Germany
Wiesbaden, Germany, 65199
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Paul Kristjansen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00523380     History of Changes
Other Study ID Numbers: NN028-1802, 2007-001506-25
Study First Received: August 30, 2007
Last Updated: October 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014