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Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

2019-10-18 11:21:38 | BioPortfolio

Summary

The purpose of this study is to enable patients, who are currently receiving rogaratinib in a Bayer-sponsored clinical trial (incl. NCT01976741), to continue treatment after their respective study has been closed. Another aim is to learn if rogaratinib is safe and how it affects the body.

Rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. The drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (FGFR) that are needed for the survival of the cancer cells.

Description

The primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug.

The secondary objective is to investigate the tolerability of rogaratinib.

Study Design

Conditions

Cancer

Intervention

Rogaratinib (BAY1163877), Combination drug

Location

Severance Hospital, Yonsei University College of Medicine
Seoul
Sankt Gallen
Korea, Republic of
03722

Status

Not yet recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-18T11:21:38-0400

Clinical Trials [1353 Associated Clinical Trials listed on BioPortfolio]

Rogaratinib (BAY1163877) in Chinese Patients

This study is planned to determine the safety and tolerability of rogaratinib in Chinese patients with fibroblast growth factor receptor (FGFR)-positive refractory, locally advanced, or me...

Rogaratinib (BAY1163877) Human Mass Balance Study

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution. For fur...

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locall...

Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

Study 19131 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study c...

Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

The primary objective of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of rogaratinib in combination with cop...

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