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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Cancer; Ovarian Cancer

Treatments: Drug: recombinant interleukin-21; Drug: caelyx (pegylated liposomal doxorubicin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523380

2007-001506-25 (EudraCT Number)

NN028-1802

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A

Experimental group

Treatment:

Drug: caelyx (pegylated liposomal doxorubicin)

Drug: recombinant interleukin-21