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| ID | Type | Description | Link |
|---|---|---|---|
| 42756493LUC2001 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of this study is to evaluate objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC), urothelial cancer, esophageal cancer and cholangiocarcinoma.
This is an open-label (all people know the identity of the intervention), multicenter, phase 2 study to evaluate the clinical efficacy, safety and pharmacokinetics of erdafitinib in Asian participants with advanced NSCLC, urothelial cancer, esophageal cancer and cholangiocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erdafitinib | Experimental | Participants will receive a 8 milligram (mg) starting dose once daily with option to up-titrate to 9 mg on a 28-day cycle. The dose of study drug may be modified, delayed, or terminated based on guidelines provided in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erdafitinib | Drug | Participants will receive 8 mg of erdafitinib, once daily with option to up-titrate to 9 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria. | From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first. | From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39138436 | Derived | Park JO, Feng YH, Su WC, Oh DY, Keam B, Shen L, Kim SW, Liu X, Liao H, Qing M, Zhang C, Qian J, Tang X, Li P, Triantos S, Sweiti H. Erdafitinib in Asian patients with advanced solid tumors: an open-label, single-arm, phase IIa trial. BMC Cancer. 2024 Aug 13;24(1):1006. doi: 10.1186/s12885-024-12584-0. |
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| Duration Of Response (DOR) | Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. | From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years) |
| Disease Control Rate (DCR) | DCR defined as the proportion of participants with complete response [CR], partial response [PR], or greater than or equal to (>=) 6 weeks stable disease [SD]). | From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years) |
| Overall Survival (OS) | The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive. | From the date of the first dose of study drug until death, or withdrawal of consent or long-term extension (LTE) phase initiates, whichever occurs first (approximately 2 years) |
| Number of Participants With an Adverse Event | Screening up to end of study (approximately 2 years) |
| Plasma Concentration of Erdafitinib | Approximately up to 16 weeks |
| Harbin |
| China |
| Nanjing | China |
| Seoul | South Korea |
| Kaohsiung City | Taiwan |
| Tainan | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000168 | Acrocephalosyndactylia |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004938 | Esophageal Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D003398 | Craniosynostoses |
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013576 | Syndactyly |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D017880 | Limb Deformities, Congenital |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000604580 | erdafitinib |
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