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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemigatinib — DRUG
• Gemcitabine — DRUG
• Pembrolizumab — DRUG
• Docetaxel — DRUG
• Trastuzumab — DRUG
• Retifanlimab — DRUG
• Cisplatin — DRUG

Study Details

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).

Key Dates

Start date

Feb 27, 2015

Status verified

Dec 2022

Primary completion

Dec 17, 2021

Completion

Dec 17, 2021

Study Design

Enrollment

201 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Intermittent pemigatinib 1/2/4 mg QD
  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.
• Experimental: Part 1: Intermittent pemigatinib 6 mg QD
  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.
• Experimental: Part 1: Intermittent pemigatinib 9 mg QD
  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.
• Experimental: Part 1: Intermittent pemigatinib 13.5 mg QD
  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.
• Experimental: Part 1: Intermittent pemigatinib 20 mg QD
  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.
• Experimental: Part 1: Continuous pemigatinib 9 mg QD
  Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 1: Continuous pemigatinib 13.5 mg QD
  Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 1: Continuous pemigatinib 20 mg QD
  Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 1: Continuous pemigatinib 7.5 mg BID
  Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 1: Continuous pemigatinib 10 mg BID
  Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 2: Intermittent pemigatinib 9 mg QD
  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.
• Experimental: Part 2: Intermittent pemigatinib 13.5 mg QD
  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.
• Experimental: Part 2: Continuous pemigatinib 9 mg QD
  Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 2: Continuous pemigatinib 13.5 mg QD
  Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 2: Continuous pemigatinib 20 mg QD
  Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
• Experimental: Part 3: Gem/Cis/intermittent pemigatinib 9 mg
  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.
• Experimental: Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg
  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.
• Experimental: Part 3: Tras/intermittent pemigatinib 13.5 mg
  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.
• Experimental: Part 3: Doc/intermittent pemigatinib 13.5 mg
  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.
• Experimental: Part 3: Pem/intermittent pemigatinib 9 mg
  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.
• Experimental: Part 3: Pem/intermittent pemigatinib 13.5 mg
  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.
• Experimental: Part 3: Pem/continuous pemigatinib 13.5 mg
  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.
• Experimental: Part 3: Ref/continuous pemigatinib 9 mg
  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.
• Experimental: Part 3: Ref/continuous pemigatinib 13.5 mg
  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.
• Experimental: Part 3: Ref/continuous pemigatinib 20 mg
  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 Measure

Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to 763 days ]

Locations (19)

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