Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
Status and phase
Terminated
Phase 2
Phase 1
Conditions
Endometrial Cancer
Solid Tumor
Breast Cancer
Multiple Myeloma
Gastric Cancer
Myeloproliferative Neoplasms
Urothelial Cancer
Lung Cancer
Cholangiocarcinoma
MPN
UC
Treatments
Drug: Trastuzumab
Drug: Docetaxel
Drug: Cisplatin
Drug: Pembrolizumab
Drug: Retifanlimab
Drug: Gemcitabine
Drug: Pemigatinib
Details and patient eligibility
About
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).
Enrollment
201 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
201 participants in 25 patient groups
Part 1: Intermittent pemigatinib 1/2/4 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 1: Intermittent pemigatinib 6 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 1: Intermittent pemigatinib 9 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 1: Intermittent pemigatinib 13.5 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 1: Intermittent pemigatinib 20 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 1: Continuous pemigatinib 9 mg QD
Experimental group
Description:
Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 1: Continuous pemigatinib 13.5 mg QD
Experimental group
Description:
Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 1: Continuous pemigatinib 20 mg QD
Experimental group
Description:
Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 1: Continuous pemigatinib 7.5 mg BID
Experimental group
Description:
Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 1: Continuous pemigatinib 10 mg BID
Experimental group
Description:
Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 2: Intermittent pemigatinib 9 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 2: Intermittent pemigatinib 13.5 mg QD
Experimental group
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.
Treatment:
Drug: Pemigatinib
Part 2: Continuous pemigatinib 9 mg QD
Experimental group
Description:
Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 2: Continuous pemigatinib 13.5 mg QD
Experimental group
Description:
Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 2: Continuous pemigatinib 20 mg QD
Experimental group
Description:
Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
Treatment:
Drug: Pemigatinib
Part 3: Gem/Cis/intermittent pemigatinib 9 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Cisplatin
Drug: Gemcitabine
Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Cisplatin
Drug: Gemcitabine
Part 3: Tras/intermittent pemigatinib 13.5 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Trastuzumab
Part 3: Doc/intermittent pemigatinib 13.5 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Docetaxel
Part 3: Pem/intermittent pemigatinib 9 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Pembrolizumab
Part 3: Pem/intermittent pemigatinib 13.5 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Pembrolizumab
Part 3: Pem/continuous pemigatinib 13.5 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Pembrolizumab
Part 3: Ref/continuous pemigatinib 9 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Retifanlimab
Part 3: Ref/continuous pemigatinib 13.5 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Retifanlimab
Part 3: Ref/continuous pemigatinib 20 mg
Experimental group
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.
Treatment:
Drug: Pemigatinib
Drug: Retifanlimab
Trial contacts and locations
20
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Data sourced from clinicaltrials.gov
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