Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
- Conditions
- UCMPNLung CancerSolid TumorGastric CancerUrothelial CancerEndometrial CancerMultiple MyelomaMyeloproliferative NeoplasmsBreast Cancer
- Interventions
- Registration Number
- NCT02393248
- Lead Sponsor
- Incyte Corporation
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 201
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Intermittent pemigatinib 1/2/4 mg QD Pemigatinib 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. Part 1: Intermittent pemigatinib 6 mg QD Pemigatinib 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. Part 1: Intermittent pemigatinib 9 mg QD Pemigatinib 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. Part 1: Intermittent pemigatinib 13.5 mg QD Pemigatinib 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. Part 1: Intermittent pemigatinib 20 mg QD Pemigatinib 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. Part 1: Continuous pemigatinib 9 mg QD Pemigatinib Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. Part 1: Continuous pemigatinib 10 mg BID Pemigatinib Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle. Part 2: Intermittent pemigatinib 9 mg QD Pemigatinib 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. Part 2: Intermittent pemigatinib 13.5 mg QD Pemigatinib 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. Part 2: Continuous pemigatinib 9 mg QD Pemigatinib Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle. Part 2: Continuous pemigatinib 13.5 mg QD Pemigatinib Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. Part 2: Continuous pemigatinib 20 mg QD Pemigatinib Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. Part 3: Gem/Cis/intermittent pemigatinib 9 mg Cisplatin 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. Part 3: Doc/intermittent pemigatinib 13.5 mg Docetaxel 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. Part 3: Pem/intermittent pemigatinib 9 mg Pembrolizumab 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. Part 3: Pem/intermittent pemigatinib 13.5 mg Pembrolizumab 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. Part 3: Pem/continuous pemigatinib 13.5 mg Pembrolizumab 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. Part 1: Continuous pemigatinib 13.5 mg QD Pemigatinib Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. Part 1: Continuous pemigatinib 20 mg QD Pemigatinib Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle. Part 1: Continuous pemigatinib 7.5 mg BID Pemigatinib Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle. Part 3: Gem/Cis/intermittent pemigatinib 9 mg Pemigatinib 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. Part 3: Gem/Cis/intermittent pemigatinib 9 mg Gemcitabine 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. Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg Pemigatinib 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. Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg Gemcitabine 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. Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg Cisplatin 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. Part 3: Tras/intermittent pemigatinib 13.5 mg Pemigatinib 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. Part 3: Doc/intermittent pemigatinib 13.5 mg Pemigatinib 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. Part 3: Tras/intermittent pemigatinib 13.5 mg Trastuzumab 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. Part 3: Pem/intermittent pemigatinib 9 mg Pemigatinib 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. Part 3: Pem/intermittent pemigatinib 13.5 mg Pemigatinib 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. Part 3: Pem/continuous pemigatinib 13.5 mg Pemigatinib 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. Part 3: Ref/continuous pemigatinib 9 mg Pemigatinib 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. Part 3: Ref/continuous pemigatinib 9 mg Retifanlimab 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. Part 3: Ref/continuous pemigatinib 20 mg Pemigatinib 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. Part 3: Ref/continuous pemigatinib 13.5 mg Pemigatinib 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. Part 3: Ref/continuous pemigatinib 13.5 mg Retifanlimab 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. Part 3: Ref/continuous pemigatinib 20 mg Retifanlimab 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.
- Primary Outcome Measures
Name Time Method Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) up to 763 days 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.
Part 3: Number of Participants With Any TEAE up to 869 days 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.
E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in 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 E0 was defined as the Baseline serum concentration of phosphate.
EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in 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 EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in 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 Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in 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 Serum phosphate concentration was assessed throughout Parts 1 and 2.
- Secondary Outcome Measures
Name Time Method Part 2: Overall Response Rate (ORR) up to 126 days 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.
Part 3: ORR up to 203 days 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.
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 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 Cmax was defined as the maximum observed plasma concentration.
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 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 tmax was defined as the time to the maximum observed plasma concentration.
Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 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 AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1 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 AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 Cmax was defined as the maximum observed plasma concentration.
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 tmax was defined as the time to the maximum observed plasma concentration.
Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 Cmin was defined as the minimum observed plasma concentration over the dose interval.
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 CL/F was defined as the apparent oral dose clearance.
Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 Vz/F was defined as the apparent volume of distribution.
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 Cmax was defined as the maximum observed plasma concentration.
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 tmax was defined as the time to the maximum observed plasma concentration.
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose 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 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 Cmax was defined as the maximum observed plasma concentration.
Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State) 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 The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 tmax was defined as the time to the maximum observed plasma concentration.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 CL/F was defined as the apparent oral dose clearance.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 Vz/F was defined as the apparent volume of distribution.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 Cmax was defined as the maximum observed plasma concentration.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 Cmin was defined as the minimum observed plasma concentration over the dose interval.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 Cmin was defined as the minimum observed plasma concentration over the dose interval.
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 Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14 AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1 predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose 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 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 tmax was defined as the time to the maximum observed plasma concentration.
Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 CL/F was defined as the apparent oral dose clearance.
Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 Vz/F was defined as the apparent volume of distribution.
Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State) predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14 The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
Trial Locations
- Locations (20)
Ohio State University - Wexner Medical Center
🇺🇸Columbus, Ohio, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Alabama At Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Hematology Oncology Associates of the Tr
🇺🇸Port Saint Lucie, Florida, United States
Cedars-Sinai Medical Center
🇺🇸West Hollywood, California, United States
John Theurer Cancer Center, Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Northwell Health - Monter Cancer Center
🇺🇸New Hyde Park, New York, United States
The Finsen Centre National Hospital
🇩🇰Copenhagen, Denmark
Mary Crowley Cancer Research Ctr
🇺🇸Dallas, Texas, United States
Signal Point Clinical Research Center
🇺🇸Middletown, Ohio, United States
Emory University - Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Greenville Health System Cancer Institute
🇺🇸Greenville, South Carolina, United States
Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Baylor Scott & White Health
🇺🇸Temple, Texas, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States