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

Phase 2

Completed

• Conditions: Cancer; Ovarian Cancer
• Interventions: Drug: recombinant interleukin-21; Drug: caelyx (pegylated liposomal doxorubicin)

• Registration Number: NCT00523380
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Study Start: 2007-10-04
• Primary Completion: 2009-01-07
• Study Completion: 2009-01-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	recombinant interleukin-21	-
A	caelyx (pegylated liposomal doxorubicin)	-

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.	after max. 6 treatment cycles

Secondary Outcome Measures

Name	Time	Method
IL-21 antibody formation	For the duration of the trial
Progression free survival	For the duration of the trial
Patient reported outcomes	For the duration of the trial
Biomarker assessments CA-125	For the duration of the trial
Pharmacokinetics	Initially

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Wiesbaden, Germany