Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004934-12 | EudraCT Number |
Not provided
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This is an open-label, single arm study to study the safety, efficacy and tolerability of Pemigatinib when used on participants with squamous or nonsquamous NSCLC with a documented FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no available standard treatment options
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Squamous NSCLC | Experimental | Participants with squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing. |
|
| Cohort B: Non-squamous NSCLC | Experimental | Participants with non-squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemigatinib | Drug | 13.5 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) in Cohort A | ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | up to 267 days |
| Measure | Description | Time Frame |
|---|---|---|
| ORR in Cohort B | ORR was defined as the percentage of participants who achieved a CR or PR based on RECIST v1.1. Response was determined by an ICR review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Luisa Veronese, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | United States | ||
| Florida Cancer Specialists & Research Institute |
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 8 study centers in Spain, Italy, France, and the United States.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Squamous NSCLC | Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2021 | Jul 10, 2024 |
Not provided
Participants enrolled in this study will be assigned to 1 of 2 cohorts: Cohort A (squamous NSCLC) will enroll approximately 100 participants, and Cohort B (nonsquamous NSCLC) will enroll approximately 25 participants.
Not provided
Not provided
Not provided
Not provided
| up to 80 days |
| Progression-free Survival (PFS) in Cohort A | PFS was defined as the time from the first dose of study treatment until progressive disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. PD was defined as the progression of a target or non-target lesion or presence of a new lesion. | up to 267 days |
| Duration of Response (DOR) in Cohort A | DOR was defined as the time from the date of the first CR or PR until the date of the first PD (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to 182 days |
| Overall Survival (OS) in Cohort A | OS was defined as the time from the first dose of study treatment to death of any cause. | up to 267 days |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. | up to 302 days |
| Number of Participants With Any Treatment-related TEAE According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The investigator assessed the relationship between study drug and each occurrence of each AE/serious adverse event. | up to 302 days |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Memorial Healthcare System | Pembroke Pines | Florida | 33028 | United States |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | United States |
| Spoknwrd Clinical Trials Inc. | Easton | Pennsylvania | 18045 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| H�PITAL NORD - CHU MARSEILLE | Marseille | 13385 | France |
| Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol | Toulouse | 31000 | France |
| Zentralklinik Bad Berka Gmbh | Bad Berka | 99437 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Lki Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| Irccs Centro Di Riferimento Oncologico | Aviano | 33081 | Italy |
| Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari | Bari | 70124 | Italy |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori | Meldola | 47014 | Italy |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano | Orbassano | 10043 | Italy |
| Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia | Perugia | 06132 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56124 | Italy |
| Istituto Nazionale Tumori Regina Elena Irccs | Roma | 00144 | Italy |
| Irccs Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Complejo Hospitalario Universitario A Coruna | A Coru?a | 15006 | Spain |
| Hospital General Universitario Vall D Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Ico Girona Hospital Universitari de Girona Dr Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario Ciudad de Jaen | Jaén | 23007 | Spain |
| Ico Institut Catala D Oncologia | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario de La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Hm Sanchinarro | Madrid | 28050 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| FG001 | Cohort B: Nonsquamous NSCLC | Cohort B: Nonsquamous NSCLC (Experimental) Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Squamous NSCLC | Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. |
| BG001 | Cohort B: Nonsquamous NSCLC | Cohort B: Nonsquamous NSCLC (Experimental) Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. |
| BG002 | 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 |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Objective Response Rate (ORR) in Cohort A | ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Full Analysis Population: all enrolled participants who received at least 1 dose of pemigatinib. The confidence interval was calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 267 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | ORR in Cohort B | ORR was defined as the percentage of participants who achieved a CR or PR based on RECIST v1.1. Response was determined by an ICR review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Full Analysis Population. The confidence interval was calculated based on the exact method for binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 80 days |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in Cohort A | PFS was defined as the time from the first dose of study treatment until progressive disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. PD was defined as the progression of a target or non-target lesion or presence of a new lesion. | Full Analysis Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method. | Posted | Median | 95% Confidence Interval | months | up to 267 days |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in Cohort A | DOR was defined as the time from the date of the first CR or PR until the date of the first PD (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | Full Analysis Population. Only those participants with available data were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method. | Posted | Median | 95% Confidence Interval | months | up to 182 days |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Cohort A | OS was defined as the time from the first dose of study treatment to death of any cause. | Full Analysis Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method. | Posted | Median | 95% Confidence Interval | months | up to 267 days |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. | Safety Population: all enrolled participants who received at least 1 dose of pemigatinib | Posted | Count of Participants | Participants | up to 302 days |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-related TEAE According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The investigator assessed the relationship between study drug and each occurrence of each AE/serious adverse event. | Safety Population | Posted | Count of Participants | Participants | up to 302 days |
|
up to 302 days
Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
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 A: Squamous NSCLC | Participants with squamous non-small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Cohort B: Nonsquamous NSCLC | Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. | 4 | 5 | 2 | 5 | 5 | 5 |
| EG002 | Total | Total | 5 | 8 | 2 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Skin ulcer haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 26 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2023 | Jul 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000168 | Acrocephalosyndactylia |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003398 | Craniosynostoses |
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013576 | Syndactyly |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D017880 | Limb Deformities, Congenital |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705477 | pemigatinib |
| C000629506 | INCB 54828-101 |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Cohort B: Nonsquamous NSCLC |
Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. |
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Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported. |
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