Efficacy Study of Recombinant Interleukin-21 in the Treat... | NCT00523380

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

NCT00523380

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

10Actual

Phase

Phase 2

Conditions

Cancer
Ovarian Cancer

Interventions

recombinant interleukin-21
caelyx (pegylated liposomal doxorubicin)

Countries

France
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-001506-25	EudraCT Number

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2007Actual

Primary Completion Date

Jan 7, 2009Actual

Completion Date

Jan 7, 2009Actual

First Submitted Date

Aug 30, 2007

First Submission Date that Met QC Criteria

Aug 30, 2007

First Posted Date

Aug 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: recombinant interleukin-21 Drug: caelyx (pegylated liposomal doxorubicin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
recombinant interleukin-21	Drug	Administered i.v. in treatment cycles of 28 days.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pharmacokinetics		Initially
IL-21 antibody formation		For the duration of the trial
Progression free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Lyon		69373	France
Novo Nordisk Investigational Site

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C506643	liposomal doxorubicin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided