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

NCT04125693 | Completed Phase 2

• 2 other identifiers: 202522019-000808-15
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Fibroblast growth factor receptors (FGFR) Inhibitor; FGFR 1-4; Non-small-cell lung cancer; Small-cell lung cancer; Urothelial carcinoma; Adenoidcystic carcinoma; Head cancer; Neck cancer; Breast cancer

Outcome Measures

Primary Outcomes (4)

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to 55 months

• Incidence of treatment-emergent serious adverse events (TESAEs)

  Up to 55 months

• Incidence of drug-related TEAEs

  Up to 55 months

• Incidence of drug-related TESAEs

  Up to 55 months

Secondary Outcomes (1)

• Frequency of dose modifications

  Up to 55 months

Study Arms (1)

Cancer patients

EXPERIMENTAL

Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.

Drug: Rogaratinib (BAY1163877); Drug: Combination drug

Interventions

Rogaratinib (BAY1163877) DRUG

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

Also known as: FGFR 1-4 inhibitor

Cancer patients

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.

Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Kantonsspital St. Gallen

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

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Conditions

Neoplasms; Acrocephalosyndactylia; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Carcinoma, Transitional Cell; Head and Neck Neoplasms; Breast Neoplasms

Interventions

Rogaratinib; Drug Combinations

Condition Hierarchy (Ancestors)

Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 14, 2019
• Study Start: October 30, 2019
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

CH (1)