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

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.

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Key information

Conditions

Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Practice, Elstra, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Indication for Irinotecan according to the SmPC and treating physician

Exclusion criteria

according to the Irinotecan SmPC

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Onkovis GmbH

Industry

Collaborators

AKP Freiburg GmbH

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Apr 25, 2013
Registry last updated: May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed