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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005085-19 | EudraCT Number |
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The study was terminated early due to limited efficacy in Cohorts 2 and 3 (exploratory endpoints). Termination was not due to concerns about safety and had no impact on the primary efficacy analysis (ie, results reported for Cohort 1).
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| Name | Class |
|---|---|
| Helsinn Healthcare SA | INDUSTRY |
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This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.
Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations or other FGFR genetic alterations have been enrolled. Subjects must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/metastatic disease. Subjects should have had evidence of progressive disease following their prior regimen or if prior treatment was discontinued due to toxicity must have continued evidence of measurable disease. Up to approximately 160 adult patients over age 18, both male and female were planned for enrollment.
Three cohorts of subjects comprise the study population:
Cohort 1: subjects with FGFR2 gene fusions (ie, fusions or rearrangements [formerly translocations]).
Cohort 2: subjects with FGFR genetic alterations other than FGFR2 gene fusions or rearrangements.
Cohort 3: subjects with FGFR2 gene fusions or rearrangements who have received a prior FGFR inhibitor.
All subjects received oral BGJ398 (infigratinib), once-daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle consists of 28 days.
Notes:
Cohort 1 was pre-specified as the primary analysis population. Results of these analyses were previously disclosed (posted 22 June 2022). There were no additional efficacy or safety endpoints to assess in Cohort 1 after primary completion (01 March 2021).
Cohorts 2 and 3 were added at protocol amendment (PA) 4 to support only exploratory efficacy objectives of the study. These cohorts were ongoing the time of primary completion (01 March 2021). After interim review of the data from these cohorts (as permitted by the protocol) only limited efficacy was observed and the sponsor terminated the study early. Therefore, a formal efficacy analysis was not performed for Cohorts 2 and 3. However, baseline characteristics and safety data were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGJ398 (infigratinib) | Experimental | To estimate the anti-tumor activity of BGJ398 (infigratinib) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGJ398 (infigratinib) | Drug | Capsule for oral use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR) | ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Assessed by the Investigator | ORR is defined as the percentage (%) of subjects with a best overall response of CR or PR, evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) only. These results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Growth Modulation Index (GMI) | The GMI is defined as the ratio of PFS (months) during treatment with infigratinib relative to the time (months) to progression (TTP) during treatment with last prior line of therapy. Subjects served as their own control. Results are provided for both BICR and Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
Inclusion criteria:
- Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.
Patients with cancers of the gallbladder or ampulla of Vater are not eligible.
- Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.
Exclusion criteria:
Prior or current treatment with a MEK inhibitor (all Cohorts), BGJ398 (infigratinib) (all Cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).
insufficient organ function
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| QED Therapeutics | QED Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QED Investigative Site | Phoenix | Arizona | 85054 | United States | ||
| QED Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34358484 | Derived | Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):803-815. doi: 10.1016/S2468-1253(21)00196-5. Epub 2021 Aug 3. | |
| 29182496 |
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Subjects meeting inclusion/exclusion criteria were enrolled into the following cohorts:
Cohort 1 (FGFR2 fusions): Primary analysis population (N=108). Cohort 2 (Other FGFR alterations): N=25. Cohort 3 (FGFR2 fusions and prior FGFR inhibitor): N=10.
Note:
Primary efficacy outcome measures were prespecified only for Cohort 1. Cohorts 2 and 3 were added following PA 4 to support exploratory objectives only.
Cohorts 2 and 3 are not the primary analysis population.
Participants with a diagnosis of advanced or metastatic cholangiocarcinoma were recruited to this open-label, single-arm global study across 20 centers (9 in the US, 5 in W. Europe, 6 in Asia) based on documented evidence of FGFR gene alteration. The first participant was treated on 23 July 2014. The data cutoff for the primary analysis (Cohort 1 only) was 01 March 2021.The data cutoff for the final analysis (Cohort 2 and 3 only) was 07 February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: FGFR2 Fusions | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) |
| FG001 | Cohort 2: Other FGFR Alterations | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) |
| 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 | Jan 15, 2020 | Feb 19, 2022 |
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| Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021. |
| Best Overall Response (BOR) | BOR is defined as the best overall response a subject achieved during the study before any subsequent antineoplastic therapy. The endpoint is summarized for the rate of BOR of CR, PR, progressive disease (PD), and stable disease (SD), evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. PD: at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusion) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Disease Control Rate (DCR) | DCR is the percentage (%) of subjects with a BOR of CR, PR, or SD, evaluated by CT or MRI scans every 28 days. Results are based on both BICR and on Investigator assessment. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Progression-Free Survival (PFS) | PFS was calculated as the number of months from the first dose of study drug to the first documented progression or death due to any cause, whichever occurred earlier. Subjects without an assessment of progression or death were censored at the last adequate tumor assessment. For subjects who had an event after ≥2 missed visits, the subject was censored at the last adequate tumor assessment before the missing visit. Disease progression was assessed per RECIST (v1.1) and defined as at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. Results are based on both BICR and on Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Overall Survival (OS) | OS was defined as the time (months) from the date of start of treatment to the date of death due to any cause. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Duration of Response (DOR) | DOR is defined as the time (months) from the initial response to the time of the event; defined as the first documented progression or death due to any cause, whichever was earlier. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Response Onset | Response onset was defined as the time (months) from the first study treatment administration date to the initial response. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| Los Angeles |
| California |
| 90033 |
| United States |
| QED Investigative Site | Los Angeles | California | 90095 | United States |
| QED Investigative Site | San Francisco | California | 94158 | United States |
| QED Investigative Site | Boston | Massachusetts | 02114 | United States |
| QED Investigative Site | Detroit | Michigan | 48201 | United States |
| QED Investigative Site | New York | New York | 10016 | United States |
| QED Investigative Site | New York | New York | 10029 | United States |
| QED Investigative Site | New York | New York | 10065 | United States |
| QED Investigative Site | Columbus | Ohio | 43221 | United States |
| QED Investigative Site | Houston | Texas | 77030-4009 | United States |
| QED Investigative Site | Brussels | 1200 | Belgium |
| QED Investigative Site | Leuven | 3000 | Belgium |
| QED Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| QED Investigative Site | Heidelberg | 69120 | Germany |
| QED Investigative Site | Tübingen | Germany |
| QED Investigative Site | Ancona | AN | 60126 | Italy |
| QED Investigative Site | Milan | MI | 20132 | Italy |
| QED Investigative Site | Roma | RM | 00168 | Italy |
| QED Investigative Site | Moscow | 125367 | Russia |
| QED Investigative Site | Volzhskiy | 404133 | Russia |
| QED Investigative Site | Singapore | 119228 | Singapore |
| QED Investigative Site | Singapore | 169610 | Singapore |
| QED Investigative Site | Seoul | Korea | 03080 | South Korea |
| QED Investigative Site | Seoul | Korea | 06351 | South Korea |
| QED Investigative Site | Barcelona | 8035 | Spain |
| QED Investigative Site | Barcelona | 8908 | Spain |
| QED Investigative Site | Madrid | 28050 | Spain |
| QED Investigative Site | Taipei | Taiwan ROC | 10041 | Taiwan |
| QED Investigative Site | Zhunan | 35053 | Taiwan |
| QED Investigative Site | Khon Kaen | THA | 40002 | Thailand |
| QED Investigative Site | Bangkok | 10330 | Thailand |
| QED Investigative Site | Bangkok | 10400 | Thailand |
| QED Investigative Site | Bebington | CH63 4JY | United Kingdom |
| QED Investigative Site | Birmingham | B15 2TH | United Kingdom |
| QED Investigative Site | Manchester | M20 4BX | United Kingdom |
| QED Investigative Site | Nottingham | NG5 1PB | United Kingdom |
| Derived |
| Javle M, Lowery M, Shroff RT, Weiss KH, Springfeld C, Borad MJ, Ramanathan RK, Goyal L, Sadeghi S, Macarulla T, El-Khoueiry A, Kelley RK, Borbath I, Choo SP, Oh DY, Philip PA, Chen LT, Reungwetwattana T, Van Cutsem E, Yeh KH, Ciombor K, Finn RS, Patel A, Sen S, Porter D, Isaacs R, Zhu AX, Abou-Alfa GK, Bekaii-Saab T. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. J Clin Oncol. 2018 Jan 20;36(3):276-282. doi: 10.1200/JCO.2017.75.5009. Epub 2017 Nov 28. |
| 25763789 | Derived | Borad MJ, Gores GJ, Roberts LR. Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma. Curr Opin Gastroenterol. 2015 May;31(3):264-8. doi: 10.1097/MOG.0000000000000171. |
| FG002 | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) |
| Treatment Ongoing |
|
| Treatment Ended | Per protocol, patients continue treatment until radiographical documentation of disease progression. |
|
| COMPLETED | Cohort 1: completed is defined as patients who had the opportunity to be followed for at least 10 months after their initial exposure of infigratinib. This cohort supports the primary efficacy analysis of the study Cohort 2 and 3: completed is defined as patients who may have had the opportunity to be followed for at least 10 months after their initial exposure of infigratinib or up to the time of study termination. These cohorts support only the exploratory endpoints of the study |
|
| NOT COMPLETED |
|
Full Analysis Set (FAS), defined as all subjects who had received at least 1 dose of infigratinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: FGFR2 Fusions | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) |
| BG001 | Cohort 2: Other FGFR Genetic Alterations | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) |
| BG002 | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| ECOG PS | Functional status was assessed at baseline using the Eastern Cooperative Oncology Group Performance Scale (ECOG PS), defined as follows: 0. Fully active, able to carry out all pre-disease performance without restriction.
| Count of Participants | Participants |
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| Primary site of cancer | Count of Participants | Participants |
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| Non-Liver Metastatic Site | Count of Participants | Participants |
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| Non-Liver Metastatic Site | Data represent the number of patients in the FAS with at least one metastatic site. Note that for some patients, metastases may have been reported at more than one site. | Count of Participants | Participants |
| ||||||||||
| Time from initial diagnosis to first dose day | Median | Full Range | months |
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| Time from the most recent recurrence/progression to the first dose day | The date of most recent recurrence/progression is based on medical history which may not have been available for all patients. | Median | Full Range | months |
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| Histological Grade | Count of Participants | Participants |
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| Stage at Time of Study Entry | The AJCC staging manual (7th edition) for intrahepatic cholangiocarcinoma was used for cancer staging at baseline, defined as follows: Stage I: solitary tumor without vascular invasion. Stage II: solitary tumor with vascular invasion or multiple tumors with or without vascular invasion. Stage III: tumor perforating the visceral peritoneum or involving local hepatic structure by direct invasion. Stage IV: tumor with periductal invasion, or any tumor with regional lymph node metastasis present, or any tumor with or without lymph node metastasis but metastasized to a distant site. | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR) | ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Posted | Number | 95% Confidence Interval | Percentage (%) of subjects with CR or PR | Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
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| Secondary | Overall Response Rate (ORR) as Assessed by the Investigator | ORR is defined as the percentage (%) of subjects with a best overall response of CR or PR, evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) only. These results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Posted | Number | 95% Confidence Interval | Percentage (%) of subjects with CR or PR | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021. |
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| Secondary | Best Overall Response (BOR) | BOR is defined as the best overall response a subject achieved during the study before any subsequent antineoplastic therapy. The endpoint is summarized for the rate of BOR of CR, PR, progressive disease (PD), and stable disease (SD), evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. PD: at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusion) | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Posted | Count of Participants | Participants | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
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| Secondary | Disease Control Rate (DCR) | DCR is the percentage (%) of subjects with a BOR of CR, PR, or SD, evaluated by CT or MRI scans every 28 days. Results are based on both BICR and on Investigator assessment. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Posted | Number | 95% Confidence Interval | Percentage (%) with CR, PR, or SD | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
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| Secondary | Progression-Free Survival (PFS) | PFS was calculated as the number of months from the first dose of study drug to the first documented progression or death due to any cause, whichever occurred earlier. Subjects without an assessment of progression or death were censored at the last adequate tumor assessment. For subjects who had an event after ≥2 missed visits, the subject was censored at the last adequate tumor assessment before the missing visit. Disease progression was assessed per RECIST (v1.1) and defined as at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. Results are based on both BICR and on Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Posted | Median | 95% Confidence Interval | months | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
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| Secondary | Overall Survival (OS) | OS was defined as the time (months) from the date of start of treatment to the date of death due to any cause. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Posted | Median | 95% Confidence Interval | months | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
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| Secondary | Duration of Response (DOR) | DOR is defined as the time (months) from the initial response to the time of the event; defined as the first documented progression or death due to any cause, whichever was earlier. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35). | Posted | Median | 95% Confidence Interval | months | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| |||||||||||||||||||||||||||
| Secondary | Response Onset | Response onset was defined as the time (months) from the first study treatment administration date to the initial response. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35). | Posted | Median | Full Range | months | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Growth Modulation Index (GMI) | The GMI is defined as the ratio of PFS (months) during treatment with infigratinib relative to the time (months) to progression (TTP) during treatment with last prior line of therapy. Subjects served as their own control. Results are provided for both BICR and Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects with both a PFS measure while on infigratinib and available TTP for their last prior line of therapy (N = 103). | Posted | Median | Full Range | Ratio (PFS/TTP) in Months | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
|
| ||||||||||||||||||||||||||
| Post-Hoc | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on ORR | Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment. Investigator-assessed ORR was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed ORR was then calculated in the same subjects after third- or later-line infigratinib therapy. ORR is defined as the percentage (%) of patients with CR or PR, per RECIST (v1.1). RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (22 June 2022). No formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N = 59). | Posted | Number | 95% Confidence Interval | Percentage (%) of patients with CR or PR | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
| |||||||||||||||||||||||||||
| Post-Hoc | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on PFS | Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment. Investigator-assessed PFS was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed PFS was then calculated in the same subjects after third- or later-line infigratinib therapy. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59). | Posted | Median | 95% Confidence Interval | months | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
|
| ||||||||||||||||||||||||||
| Post-Hoc | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR | Post-hoc subgroup assessment of efficacy in those subjects who were receiving infigratinib as a third or later line of treatment. Investigator-assessed BOR was obtained from subjects' medical histories to provide a baseline evaluation of their response after historical second-line antineoplastic treatment prior to infigratinib treatment. Investigator-assessed BOR was then calculated in the same subjects after third- or later-line infigratinib therapy. The endpoint is summarized for the rate of BOR of PD, SD, PR, and CR. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59). | Posted | Count of Participants | Participants | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. |
|
|
From first administration of infigratinib with follow-up of at least 10 months after initial exposure. Data cutoff for Cohort 1 (primary analysis population) was 01 March 2021 (disclosed 22 June 2022). Data cutoff for Cohorts 2 and 3 (exploratory analysis only) was 07 February 2022.
Adverse events (AEs) were assessed by the investigator according to CTCAE v4.03 and coded using MedDRA v21.0.
Unless otherwise specified, treatment-emergent AEs are reported. AEs were considered treatment-emergent if they occurred on or after the first dose through the date of last dose +30 days.
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 | Cohort 1: FGFR2 Fusions | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) | 93 | 108 | 35 | 108 | 107 | 108 |
| EG001 | Cohort 2: Other FGFR Genetic Alterations | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) | 19 | 25 | 11 | 25 | 25 | 25 |
| EG002 | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | Infigratinib 125 mg once daily (3 wk on/1 wk off treatment) | 7 | 10 | 2 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Noninfective sialoadenitis | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Biliary abscess | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA version 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Chorioretinopathy | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Retinal drusen | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Trichomegaly | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| vitreous detachment | Eye disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA version 21.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David van Veenhuyzen, Vice President, Clinical Development | QED Therapeutics, Inc. | 1 650 391-9740 | 103 | david.vanveenhuyzen@bridgebio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2020 | Feb 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C568950 | infigratinib |
Not provided
Not provided
Not provided
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|
|
|
|
|
| Participants |
|
|
| Progressive Disease |
|
| Not Done |
|
| Progressive disease |
|
| Unknown |
|
| Not done |
|