Rogaratinib has been evaluated in multiple clinical trials spanning Phase I through Phase III for advanced and metastatic malignancies, including urothelial carcinoma, metastatic breast cancer, advanced sarcomas, and squamous-cell non-small cell lung cancer. Sponsored by pharmaceutical entities such as Bayer and academic institutions including the National Cancer Institute, Dana-Farber Cancer Institute, and Swiss Cancer Institute, these studies assess both monotherapy and combination regimens. The recruitment statuses across these investigations range from active and completed to terminated or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04595747 | ACTIVE_NOT_RECRUITING | Locally Advanced Gastrointestinal Stromal Tumor; Locally Advanced Sarcoma; Metastatic Gastrointestinal Stromal Tumor; Metastatic Sarcoma; Stage III Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8; Stage III Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8; Stage IV Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8; Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8 |
National Cancer Institute (NCI) |
2021-05-03 | PHASE2 |
| NCT04483505 | COMPLETED | Breast Cancer Metastatic; Hormone Receptor Positive Malignant Neoplasm of Breast |
Fundacion CRIS de Investigación para Vencer el Cáncer |
2020-11-25 | PHASE1 |
| NCT03762122 | TERMINATED | Squamous-cell Non-small Cell Lung Cancer |
Swiss Cancer Institute |
2019-07-25 | PHASE2 |
| NCT03473756 | COMPLETED | Urothelial Carcinoma |
Bayer |
2018-05-15 | PHASE1 |
| NCT04125693 | COMPLETED | Cancer |
Bayer |
2019-10-30 | PHASE2 |
| NCT03517956 | COMPLETED | Advanced or Metastatic Solid Tumor |
Bayer |
2018-07-25 | PHASE1 |
| NCT03410693 | COMPLETED | Carcinoma, Transitional Cell |
Bayer |
2018-05-31 | PHASE2; PHASE3 |
| NCT04040725 | WITHDRAWN | Bladder Cancer |
Dana-Farber Cancer Institute |
2019-11-27 | PHASE2 |
| NCT03788603 | COMPLETED | Neoplasms |
Bayer |
2019-01-07 | PHASE1 |
| NCT01976741 | COMPLETED | Neoplasms |
Bayer |
2013-12-30 | PHASE1 |
| NCT03484585 | COMPLETED | Clinical Trial, Phase I; Pharmacokinetics |
Bayer |
2018-04-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-31)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).