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

Completed

• Conditions: Carcinoma

• Registration Number: NCT01840280
• Lead Sponsor: Onkovis GmbH

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 available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Indication for Irinotecan according to the SmPC and treating physician

Exclusion Criteria

• according to the Irinotecan SmPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Quantity of Irinotecan onkovis needed per treatment cycle	up to 24 weeks	Determine the quantity of Irinotecan onkovis needed pro treatment cycle

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Practice; 🇩🇪 Werdau, Germany