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Completed

NCT Number: NCT04125693

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

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.

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Key information

Conditions

Cancer Acrocephalosyndactylia Bone Diseases Bone Diseases, Developmental Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Head and Neck Neoplasms Limb Deformities, Congenital Lung Diseases Lung Neoplasms Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Syndactyly Synostosis Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants enrolled in any Bayer-sponsored rogaratinib feeder study at the time of study closure, who are currently receiving rogaratinib (monotherapy or combination therapy) and are experiencing clinical benefit from treatment, determined by the treating physician.
  • Participants who meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder study protocol.
  • Any ongoing adverse events that required temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption.
  • Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study treatment and until 6 months after stopping study treatment.

Exclusion criteria

  • Ineligibility, for medical reasons, to start the next treatment cycle in the respective feeder study.
  • Patients with a beta-human chorionic gonadotropin (hCG) test consistent with pregnancy.
  • Participants are using one or more of the prohibited medications listed in the respective feeder study protocol
  • Negative benefit / risk ratio as determined by the investigator
  • Positive pregnancy test for on-treatment participants

Treatment and study plan

Rogaratinib (BAY1163877)

Drug

Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.

Other names: FGFR 1-4 inhibitor

Combination drug

Drug

Any other drug specified in the protocol of the completed Bayer clinical trials that is used in combination with rogaratinib. Not all patients receive combination therapy.

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 55 months

  2. Incidence of treatment-emergent serious adverse events (TESAEs)

    Time frame: Up to 55 months

  3. Incidence of drug-related TEAEs

    Time frame: Up to 55 months

  4. Incidence of drug-related TESAEs

    Time frame: Up to 55 months

Secondary outcomes

  1. Frequency of dose modifications

    Time frame: Up to 55 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2019
Registry last updated
Apr 1, 2022

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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