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Completed

NCT Number: NCT03890731

A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed

The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.

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Key information

Conditions

Solid Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eberhard-Karls-Universität Tübingen, Tübingen, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant must be age-eligible in the feeder study at the time of signing the informed consent.
  • Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
  • Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
  • Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Exclusion criteria

  • Medical reasons not to start the next treatment cycle in the respective feeder
  • Pregnancy

Treatment and study plan

BAY73-4506 (Regorafenib, Stivarga)

Drug

Regorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off).

Other names: Tyrosine-kinase inhibitor

Primary outcomes

  1. Number and Severity of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

    An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    An SAE was defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc.

  2. Severity (by Worst Grade) of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

    AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. Number and Severity of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

    A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.

  4. Severity (by Worst Grade) of Participants With Drug-related Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

    A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.

    AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary outcomes

  1. Number of Participants With Dose Modifications

    Time frame: from the signing of the informed consent form (ICF) until the safety follow up-visit (a duration of approximately 46 months)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis, or Has Been Stopped Prematurely.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2019
Registry last updated
Apr 2, 2024

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.

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