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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00523380
First received: August 30, 2007
Last updated: November 9, 2009
Last verified: July 2009
History of Changes
  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
Ovarian Cancer
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: Efficacy of Recombinant Interleukin-21 in Patients With Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Locations
France
Lyon Cedex 08, France, 69373
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Paul Kristjansen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00523380     History of Changes
Other Study ID Numbers: NN028-1802, EudraCT No: 2007-001506-25
Study First Received: August 30, 2007
Last Updated: November 9, 2009
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
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013