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Clinical Trials/NCT00523380
NCT00523380CompletedPhase 2

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

Novo Nordisk A/S1 site in 1 country10 target enrollmentStarted: October 4, 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Experimental

Intervention: caelyx (pegylated liposomal doxorubicin) (Drug)

A

Experimental

Intervention: recombinant interleukin-21 (Drug)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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