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| ID | Type | Description | Link |
|---|---|---|---|
| 42756493BLC2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2014-002408-26 | EudraCT Number | ||
| 2023-510273-34-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.
This is a multicenter, open-label study (participants will know the identity of study drugs administered) to evaluate the efficacy and safety of erdafitinib in participants with urothelial cancer. The study comprises a 30-days Screening Phase, a Treatment Phase comprised of 28-day treatment cycles that will continue until disease progression or unacceptable toxicity occurs in a long-term extension (LTE) phase, and a post-treatment Follow-up Phase that will extend from the End-of-Treatment Visit until the participant has died, withdraws consent, is lost to follow-up, or the end of the study, whichever comes first. The end of study is defined as the date when all participants have completed the study treatment (Regimens 1 to 3) and all participants enrolled under the drug-drug interaction (DDI) substudy are no longer receiving treatment with erdafitinib. The purpose of DDI sub-study is to evaluate the interaction of repeated doses of erdafitinib with a sensitive cytochrome 450 (CYP) 3A substrate (midazolam) and with an organic cation transporter 2 (OCT2) probe substrate (metformin). Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erdafitinib (8 milligram) | Experimental | Prior to interim analysis 1 (IA1), there were 2 treatment regimens: Regimen 1 (10 milligram [mg] once daily, 7 days on/7 days off); and Regimen 2 (6 mg once daily for 28 days). Following IA1, Regimen 1 is closed for further enrollment and starting dose of Regimen 2 is increased to 8 mg once daily for 28 days on a 28-day cycle (referred to as Regimen 3). Participants who enrolled in DDI substudy will receive pretreatment with single doses of midazolam (Day -2) and metformin (Day -1). Participants enrolled in DDI substudy will receive 8 mg erdafitinib treatment from Day 1 to Day 15, single doses of midazolam 2.5 mg (Day 13) and metformin 1000 mg (Day 14) and erdafitinib treatment will continued until disease progression. Participants who completed the DDI substudy and continue to benefit from erdafitinib treatment, will continue to receive erdafitinib in long-term extension (LTE) phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erdafitinib | Drug | 8 mg orally once daily for 28 days on a 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Percentage of Participants With Best (Overall) Objective Response | Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR. | From Cycle 1 Day 1 up to 6 years 2 months |
| Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib | Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose |
| Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib | Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Progression-free Survival (PFS) | Progression-free survival is defined as the 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 due to any cause, whichever occurs first, regardless of the use of subsequent anticancer therapy. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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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 |
|---|---|---|---|---|---|---|
| Sedona | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35030333 | Derived | Siefker-Radtke AO, Necchi A, Park SH, Garcia-Donas J, Huddart RA, Burgess EF, Fleming MT, Rezazadeh Kalebasty A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Akapame S, Santiago-Walker AE, Monga M, O'Hagan A, Loriot Y; BLC2001 Study Group. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022 Feb;23(2):248-258. doi: 10.1016/S1470-2045(21)00660-4. Epub 2022 Jan 11. | |
| 34977972 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2022 | Sep 14, 2023 |
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| Midazolam | Drug | Participants who enrolled in DDI substudy will receive pretreatment with single dose of midazolam on Day -2 and single dose of midazolam on Day 13. |
|
| Metformin | Drug | Participants who enrolled in DDI substudy will receive pretreatment with single dose of metformin on Day -1 and single dose of metformin on Day 14. |
|
| Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib | Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib | Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Midazolam Alone or in Combination With Erdafitinib | AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Metformin Alone or in Combination With Erdafitinib | AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of metformin alone or in combination with erdafitinib. | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib | AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of 1-OH-Midazolam alone or in combination with erdafitinib. | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib | AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of metformin alone or in combination with erdafitinib | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
| From screening up to 6 years 2 months |
| Main Study: Duration of Response (DoR) | DOR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression or date of death, whatever the cause based on the RECIST version 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | From screening up to 6 years 2 months |
| Main Study: Overall Survival | Overall survival is defined as the time from the date of first dose of study drug to the date of the participant's death from any cause. | From screening up to 6 years 2 months |
| Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) | Percentage of participants with TEAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are those events that occurred from first dose date through 30 days after last dose date, or day before subsequent anticancer therapy, whichever occurs first. | From Day 1 up to 6 years 2 months |
| Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h) | C2h is the plasma concentration of erdafitinib at 2 hours. | Cycle 1 Days 1 and 21: Pre-dose up to 2 hours post-dose (each cycle length=28 days) |
| Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h) | C4h is the plasma concentration of erdafitinib at 4 hours. | Cycle 1 Days 1 and 21: Pre-dose up to 4 hours post-dose (each cycle length=28 days) |
| Los Angeles |
| California |
| United States |
| Orange | California | United States |
| Sacramento | California | United States |
| Stanford | California | United States |
| Aurora | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Chicago | Illinois | United States |
| Iowa City | Iowa | United States |
| Louisville | Kentucky | United States |
| Minneapolis | Minnesota | United States |
| Omaha | Nebraska | United States |
| Las Vegas | Nevada | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Medford | Oregon | United States |
| Tualatin | Oregon | United States |
| Hershey | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Myrtle Beach | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Denton | Texas | United States |
| Houston | Texas | United States |
| Hampton | Virginia | United States |
| Graz | Austria |
| Linz | Austria |
| Vienna | Austria |
| Aalst | Belgium |
| Brussels | Belgium |
| Charleroi | Belgium |
| Ghent | Belgium |
| Wilrijk | Belgium |
| Angers | France |
| Bordeaux | France |
| Caen Cédex 05 | France |
| Dijon | France |
| Lyon | France |
| Nice | France |
| Nîmes | France |
| Paris | France |
| Saint-Herblain | France |
| Suresnes | France |
| Villejuif | France |
| Berlin | Germany |
| Erlangen | Germany |
| Essen | Germany |
| Freiburg im Breisgau | Germany |
| Göttingen | Germany |
| Greifswald | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Heidelberg | Germany |
| München | Germany |
| Münster | Germany |
| Regensburg | Germany |
| Straubing | Germany |
| Weiden/Opf | Germany |
| Bangalore | India |
| Kolkata | India |
| Mira Road (East) | India |
| Nadiād | India |
| Beer Yaakov | Israel |
| Beersheba | Israel |
| Haifa | Israel |
| Kfar Saba | Israel |
| Petah Tikva | Israel |
| Tel Aviv | Israel |
| Chisinau | Moldova |
| Bucharest | Romania |
| Cluj-Napoca | Romania |
| Craiova | Romania |
| Iași | Romania |
| Barnaul | Russia |
| Moscow | Russia |
| Omsk | Russia |
| Pyatigorsk | Russia |
| Saint Petersburg | Russia |
| Ufa | Russia |
| Daejeon | South Korea |
| Goyang-si | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
| Badalona | Spain |
| Barcelona | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Pamplona | Spain |
| Sabadell | Spain |
| Santander | Spain |
| Santiago de Compostela | Spain |
| Seville | Spain |
| Valencia | Spain |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Istanbul | Turkey (Türkiye) |
| Blackburn | United Kingdom |
| Dundee | United Kingdom |
| Essex | United Kingdom |
| London | United Kingdom |
| Metropolitan Borough of Wirral | United Kingdom |
| Plymouth | United Kingdom |
| Sutton | United Kingdom |
| Derived |
| Dosne AG, Valade E, Goeyvaerts N, De Porre P, Avadhani A, O'Hagan A, Li LY, Ouellet D, Perez Ruixo JJ. Exposure-response analyses of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma. Cancer Chemother Pharmacol. 2022 Feb;89(2):151-164. doi: 10.1007/s00280-021-04381-4. Epub 2022 Jan 3. |
| 31340094 | Derived | Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323. |
| FG001 | Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| FG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| FG003 | Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg | Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| Treated (Safety Analysis Set) |
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| COMPLETED |
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| NOT COMPLETED |
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|
Safety analysis set included participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| BG001 | Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| BG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| BG003 | Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg | Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Main Study: Percentage of Participants With Best (Overall) Objective Response | Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR. | The population included participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | From Cycle 1 Day 1 up to 6 years 2 months |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib | Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Cycle 1 Day -2 (predose) up to Day 13 post dose |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib | Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib | Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Hours | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Hours | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib | Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Hours | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Midazolam Alone or in Combination With Erdafitinib | AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Nanograms hours per milliliter (ng*h/mL) | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng*h/mL | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
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| Primary | Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Metformin Alone or in Combination With Erdafitinib | AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of metformin alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng*h/mL | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
| |||||||||||||||||||||||||||||||||
| Primary | Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib | AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng*h/mL | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| |||||||||||||||||||||||||||||||||
| Primary | Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib | AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of 1-OH-Midazolam alone or in combination with erdafitinib. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng*h/mL | Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days) |
| |||||||||||||||||||||||||||||||||
| Primary | Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib | AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of metformin alone or in combination with erdafitinib | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng*h/mL | Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | Main Study: Progression-free Survival (PFS) | Progression-free survival is defined as the 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 due to any cause, whichever occurs first, regardless of the use of subsequent anticancer therapy. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | The population included participants who received at least 1 dose of study drug. | Posted | Median | Full Range | months | From screening up to 6 years 2 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Main Study: Duration of Response (DoR) | DOR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression or date of death, whatever the cause based on the RECIST version 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | The population included participants who received at least 1 dose of study drug and who had CR or PR. | Posted | Median | Full Range | months | From screening up to 6 years 2 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Main Study: Overall Survival | Overall survival is defined as the time from the date of first dose of study drug to the date of the participant's death from any cause. | The population included participants who received at least 1 dose of study drug. | Posted | Median | Full Range | months | From screening up to 6 years 2 months |
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| Secondary | Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) | Percentage of participants with TEAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are those events that occurred from first dose date through 30 days after last dose date, or day before subsequent anticancer therapy, whichever occurs first. | The population included participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | From Day 1 up to 6 years 2 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h) | C2h is the plasma concentration of erdafitinib at 2 hours. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Days 1 and 21: Pre-dose up to 2 hours post-dose (each cycle length=28 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h) | C4h is the plasma concentration of erdafitinib at 4 hours. | Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Days 1 and 21: Pre-dose up to 4 hours post-dose (each cycle length=28 days) |
|
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
The population included participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. | 31 | 33 | 14 | 33 | 32 | 33 |
| EG001 | Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. | 62 | 78 | 39 | 78 | 78 | 78 |
| EG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. | 83 | 101 | 47 | 101 | 101 | 101 |
| EG003 | Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg | Participants received pretreatment with single doses of midazolam 2.5 mg syrup orally on Day -2 and metformin 1000 mg tablet orally on Day -1 along with erdafitinib 8 mg tablet, orally, on 28-day cycles starting from Cycle 1 Day 1 to Day 15 (or up-titrated to 9 mg on Day 15 based on Day 14 serum PO4 levels) until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. | 3 | 25 | 9 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Angle Closure Glaucoma | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Corneal Erosion | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Detachment of Retinal Pigment Epithelium | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Maculopathy | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Optic Atrophy | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Retinal Oedema | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vitreous Detachment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Enterocutaneous Fistula | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Large Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Breakthrough Pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Condition Aggravated | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Eye Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Infective Corneal Ulcer | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pelvic Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Periorbital Abscess | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bone Contusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Exposure to Toxic Agent | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Eastern Cooperative Oncology Group Performance Status Worsened | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ureteral Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Brain Oedema | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Mental Impairment | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Device Dislocation | Product Issues | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Device Expulsion | Product Issues | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hallucination, Visual | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nephropathy Toxic | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Injury | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Pain | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urethral Stenosis | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vulvovaginal Pain | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Ocular Toxicity | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Punctate Keratitis | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Mucosal Dryness | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Taste Disorder | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nail Dystrophy | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2016 | Sep 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000604580 | erdafitinib |
| D008874 | Midazolam |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| BELGIUM |
|
| FRANCE |
|
| GERMANY |
|
| INDIA |
|
| ISRAEL |
|
| ITALY |
|
| MOLDOVA, REPUBLIC OF |
|
| ROMANIA |
|
| RUSSIAN FEDERATION |
|
| SOUTH KOREA |
|
| SPAIN |
|
| TAIWAN |
|
| TURKEY |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| Counts |
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| Participants |
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| Participants |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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|
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| OG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
|
|
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
| OG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
|
|
| OG002 |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg |
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
|
|
| OG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
|
|
| OG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
|
|
| OG002 | Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation. |
|
|