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Klinische Studien

BAY 73-4506 / 20328

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
203282018-003650-24

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

Status: Active

Purpose / Objectives

Primary Outcome

The primary purpose of the program is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial and assessed by the principal investigator (PI) to be benefitting, to continue regorafenib treatment after their respective study has reached the primary completion endpoint, or main data analysis, or has been stopped prematurely.

And the documentation of safety

Secondary Outcomes

Documentation of tolerability

Diagnosis

Patient attributes

Inclusion criteria

1. Participant must be age-eligible in the feeder study at the time of signing the informed
consent.
2. Participant is currently participating in any Bayer-sponsored regorafenib study and is
receiving study treatment.
3. 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.
4. 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.
5. Male or female
Contraceptive use by men or women should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies. This applies for the
time between signing of the informed consent form and 2 months after the last
administration of the study intervention.
Male participants:
In addition to the above methods, male trial participants and male partners of female
trial participants must also use condoms during sex as an extra measure of protection
against pregnancy.

Exclusion criteria

1. Ineligibility, for medical reasons, to start the next cycle in the respective feeder study
2. Patients with a beta-hCG test consistent with pregnancy.
3. Participants are using one or more of the prohibited medications listed in the
respective feeder study protocol. A comprehensive list can be found in Section 6.5.
4. Participant has been previously permanently discontinued from regorafenib treatment.
Diagnostic assessments
Not Applicable for this study.
5. Participant is unable to comply with the requirements of the study.

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Single-blind

Documents (password protected)

Responsibilities in overall trial

Bayer AG

  • Tel. +49 214 30-40126

Study Sites

Universitätsklinikum Köln

Study office

Status

Active

Principal Investigator

Dr. med. Dirk Waldschmidt

Contact at Site

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Standort Köln:
Universitätsklinikum Köln
Telefon: 0221 / 478-0

Standort Bonn:
Universitätsklinikum Bonn
Telefon: 0228 / 287-15332

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