Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Study Overview
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Brief Summary
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The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Official Title
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A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)

Conditions
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UC, Lung Cancer, Solid Tumor, Gastric Cancer, Urothelial Cancer, Endometrial Cancer, Multiple Myeloma, Myeloproliferative Neoplasms, Breast Cancer, Cholangiocarcinoma, MPN

Intervention / Treatment
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* Drug: Pemigatinib
* Drug: Gemcitabine
* Drug: Pembrolizumab
* Drug: Docetaxel
* Drug: Trastuzumab
* Drug: Retifanlimab
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, age 18 years or older on day of signing consent Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant) Life expectancy > 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1 Part 2 and 3: 0, 1, or 2 Exclusion Criteria: Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug Prior receipt of a selective FGFR inhibitor History of a calcium/phosphate homeostasis disorder History and/or current evidence of ectopic mineralization/calcification Current evidence of corneal disorder/keratopathy Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range Prior radiotherapy within 2 weeks of study treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Intermittent pemigatinib 1/2/4 mg QD<br>Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Intermittent pemigatinib 6 mg QD<br>Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Intermittent pemigatinib 9 mg QD<br>Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Intermittent pemigatinib 13.5 mg QD<br>Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Intermittent pemigatinib 20 mg QD<br>Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Continuous pemigatinib 9 mg QD<br>Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Continuous pemigatinib 13.5 mg QD<br>Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Continuous pemigatinib 20 mg QD<br>Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Continuous pemigatinib 7.5 mg BID<br>Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 1: Continuous pemigatinib 10 mg BID<br>Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 2: Intermittent pemigatinib 9 mg QD<br>Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 2: Intermittent pemigatinib 13.5 mg QD<br>Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 2: Continuous pemigatinib 9 mg QD<br>Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 2: Continuous pemigatinib 13.5 mg QD<br>Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 2: Continuous pemigatinib 20 mg QD<br>Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;|
| Experimental: Part 3: Gem/Cis/intermittent pemigatinib 9 mg<br>Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m^2) (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Gemcitabine<br> <br> Drug: Cisplatin<br> <br> |
| Experimental: Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg<br>Participants received gemcitabine intravenously starting at 1000 mg/m^2 (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Gemcitabine<br> <br> Drug: Cisplatin<br> <br> |
| Experimental: Part 3: Tras/intermittent pemigatinib 13.5 mg<br>Trastuzumab (Tras) was administered as an open-label, commercial product at an initial dose of 8 mg/kilograms (kg) over a 90-minute intravenous infusion, followed by 6 mg/kg over a 30- to 90-minute intravenous infusion once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Trastuzumab<br> <br> |
| Experimental: Part 3: Doc/intermittent pemigatinib 13.5 mg<br>Participants received docetaxel (Doc) intravenously starting at 75 mg/m^2 (1 hour) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Docetaxel<br> <br> |
| Experimental: Part 3: Pem/intermittent pemigatinib 9 mg<br>Participants received pembrolizumab (Pem) intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Pembrolizumab<br> <br> |
| Experimental: Part 3: Pem/intermittent pemigatinib 13.5 mg<br>Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Pembrolizumab<br> <br> |
| Experimental: Part 3: Pem/continuous pemigatinib 13.5 mg<br>Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Pembrolizumab<br> <br> |
| Experimental: Part 3: Ref/continuous pemigatinib 9 mg<br>Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Retifanlimab<br> <br> * Other names: INCMGA00012;|
| Experimental: Part 3: Ref/continuous pemigatinib 13.5 mg<br>Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Retifanlimab<br> <br> * Other names: INCMGA00012;|
| Experimental: Part 3: Ref/continuous pemigatinib 20 mg<br>Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. | Drug: Pemigatinib<br> <br> * Other names: INCB054828;Drug: Retifanlimab<br> <br> * Other names: INCMGA00012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug. | up to 763 days | 
| Part 3: Number of Participants With Any TEAE | Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug. | up to 869 days | 
| E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2 | E0 was defined as the Baseline serum concentration of phosphate. | predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles | 
| EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2 | EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate. | predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles | 
| Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2 | Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib. | predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles | 
| Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2 | Serum phosphate concentration was assessed throughout Parts 1 and 2. | predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2: Overall Response Rate (ORR) | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. 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 126 days | 
| Part 3: ORR | ORR was defined as the percentage of participants with a best overall response of CR or PR, per RECIST version 1.1, as determined by the investigator. 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 203 days | 
| Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 | Cmax was defined as the maximum observed plasma concentration. | Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1 | 
| Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 | tmax was defined as the time to the maximum observed plasma concentration. | Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1 | 
| Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 | AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration. | Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1 | 
| Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 | AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. | Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1 | 
| Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | Cmax was defined as the maximum observed plasma concentration. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | tmax was defined as the time to the maximum observed plasma concentration. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | t1/2 was defined as the apparent plasma terminal phase disposition half-life. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | Cmin was defined as the minimum observed plasma concentration over the dose interval. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | CL/F was defined as the apparent oral dose clearance. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | Vz/F was defined as the apparent volume of distribution. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) | The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose. | Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | Cmax was defined as the maximum observed plasma concentration. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | tmax was defined as the time to the maximum observed plasma concentration. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | t1/2 was defined as the apparent plasma terminal phase disposition half-life. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | Cmin was defined as the minimum observed plasma concentration over the dose interval. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | CL/F was defined as the apparent oral dose clearance. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States | Vz/F was defined as the apparent volume of distribution. | Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 | 
| Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 | Cmax was defined as the maximum observed plasma concentration. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 | 
| Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 | tmax was defined as the time to the maximum observed plasma concentration. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 | 
| Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 | AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 | 
| Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 | AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 | 
| Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | Cmax was defined as the maximum observed plasma concentration. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | tmax was defined as the time to the maximum observed plasma concentration. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | t1/2 was defined as the apparent plasma terminal phase disposition half-life. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | Cmin was defined as the minimum observed plasma concentration over the dose interval. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | CL/F was defined as the apparent oral dose clearance. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | Vz/F was defined as the apparent volume of distribution. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 
| Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) | The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose. | predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alterations in FGF or FGFR, squamous non-small cell lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma, MPN