{"preliminary_commentary":{"by_channel":{"x_thread":11},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02393248\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["pemigatinib"]],"indication":"advanced malignancies","name":"FIGHT-101","nct_id":"NCT02393248","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=fight-101-nct02393248. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"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.","label":"Part 1: Intermittent pemigatinib 1/2/4 mg QD","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 1: Intermittent pemigatinib 6 mg QD","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 1: Intermittent pemigatinib 9 mg QD","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 1: Intermittent pemigatinib 13.5 mg QD","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 1: Intermittent pemigatinib 20 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.","label":"Part 1: Continuous pemigatinib 9 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.","label":"Part 1: Continuous pemigatinib 13.5 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.","label":"Part 1: Continuous pemigatinib 20 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.","label":"Part 1: Continuous pemigatinib 7.5 mg BID","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.","label":"Part 1: Continuous pemigatinib 10 mg BID","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Intermittent pemigatinib 9 mg QD","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 2: Intermittent pemigatinib 13.5 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.","label":"Part 2: Continuous pemigatinib 9 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.","label":"Part 2: Continuous pemigatinib 13.5 mg QD","type":"EXPERIMENTAL"},{"description":"Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.","label":"Part 2: Continuous pemigatinib 20 mg QD","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Gem/Cis/intermittent pemigatinib 9 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Tras/intermittent pemigatinib 13.5 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Doc/intermittent pemigatinib 13.5 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Pem/intermittent pemigatinib 9 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Pem/intermittent pemigatinib 13.5 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Pem/continuous pemigatinib 13.5 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Ref/continuous pemigatinib 9 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Ref/continuous pemigatinib 13.5 mg","type":"EXPERIMENTAL"},{"description":"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.","label":"Part 3: Ref/continuous pemigatinib 20 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2021-12-17","type":"ACTUAL"},"conditions":["Lung Cancer","Solid Tumor","Gastric Cancer","Urothelial Cancer","Endometrial Cancer","Multiple Myeloma","Myeloproliferative Neoplasms","Breast Cancer","Cholangiocarcinoma","UC","MPN"],"enrollment":{"count":201,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pemigatinib","otherNames":["INCB054828"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"},{"name":"Trastuzumab","otherNames":[],"type":"DRUG"},{"name":"Retifanlimab","otherNames":["INCMGA00012"],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"}],"last_update":"2023-01-06","lead_sponsor":"Incyte Corporation","official_title":"A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)","overall_status":"TERMINATED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2021-12-17","type":"ACTUAL"},"primary_outcomes":[{"measure":"Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)","timeFrame":"up to 763 days"},{"measure":"Part 3: Number of Participants With Any TEAE","timeFrame":"up to 869 days"},{"measure":"E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2","timeFrame":"predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles"},{"measure":"EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2","timeFrame":"predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles"},{"measure":"Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2","timeFrame":"predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles"},{"measure":"Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2","timeFrame":"predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles"}],"references":[{"citation":"Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Feliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14.","pmid":"35176457","type":"DERIVED"},{"citation":"Gong X, Ji T, Liu X, Chen X, Yeleswaram S. Evaluation of the clinical cardiac safety of pemigatinib, a fibroblast growth factor receptor inhibitor, in participants with advanced malignancies. Pharmacol Res Perspect. 2022 Feb;10(1):e00906. doi: 10.1002/prp2.906.","pmid":"34951522","type":"DERIVED"}],"start_date":{"date":"2015-02-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)","url":"https://clinicaltrials.gov/study/NCT02393248"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/fight-101-nct02393248"}