A Non Interventional Study With Irinotecan Onkovis (Irino... | NCT01840280

Studies
A Non Interventional Study With Irinotecan Onkovis (Irinotecan) Utilized for the Treatment of Cancer

NCT01840280

Sponsor

Onkovis GmbH

Status

Completed

Last Update Posted

May 23, 2018Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Carcinoma

Interventions

Not provided

Countries

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

Status Module

Record Verification Date

May 2018

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

Apr 2013Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Apr 22, 2013

First Submission Date that Met QC Criteria

Apr 24, 2013

First Posted Date

Apr 25, 2013Estimated

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

May 22, 2018

Last Update Posted Date

May 23, 2018Actual

Name	Class
AKP Freiburg GmbH	INDUSTRY

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

The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carcinoma, Irinotecan onkovis (Irinotecan)		Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Quantity of Irinotecan onkovis needed per treatment cycle	Determine the quantity of Irinotecan onkovis needed pro treatment cycle	up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse events during and after treatment	The number and kind of adverse events during and after the intra-venous application of Irinotecan will be assessed and documented.	up to 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for Irinotecan according to the SmPC and treating physician

Exclusion Criteria:

according to the Irinotecan SmPC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated in practices, clinics, hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Practice		Elstra		01920	Germany
Practice

Condition Browse Module

MeSH Terms

ID	Term
D002277	Carcinoma
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007414	Intestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided