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

May 22, 2018 updated by: Onkovis GmbH

Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Elstra, Germany, 01920
        • Practice
      • Leipzig, Germany, 04179
        • Practice
      • Naunhof, Germany, 04683
        • Practice
      • Neustadt/Sachsen, Germany, 01844
        • Practice
      • Werdau, Germany, 08412
        • Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated in practices, clinics, hospitals

Description

Inclusion Criteria:

  • Indication for Irinotecan according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Irinotecan SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Carcinoma, Irinotecan onkovis (Irinotecan)
Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events during and after treatment
Time Frame: 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.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onkovis GmbH

Collaborators

AKP Freiburg GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONKOIRI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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