NCT00523380|CompletedPhase 2

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

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/S ClinicalTrials.gov

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2 other identifiers

NN028-18022007-001506-25

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredAug 2007

StartedOct 2007

CompletionJan 2009

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 cancer

Timeline

Completed

Started Oct 2007

Shorter than P25 for phase_2 cancer

Geographic Reach

2 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

August 30, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

October 4, 2007

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2009

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

August 30, 2007

Last Update Submit

February 28, 2017

Conditions

Cancer Ovarian Cancer

Outcome Measures

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.
after max. 6 treatment cycles

Secondary Outcomes (5)

Pharmacokinetics
Initially
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

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

recombinant interleukin-21DRUG

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

Also known as: rIL-21, NN028

caelyx (pegylated liposomal doxorubicin)DRUG

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

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.