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Completed

NCT Number: NCT00523380

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

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.

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Key information

Conditions

Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant interleukin-21

Drug

Administered i.v. in treatment cycles of 28 days.

Other names: rIL-21, NN028

caelyx (pegylated liposomal doxorubicin)

Drug

Administered i.v. in treatment cycles of 28 days.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 31, 2007
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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