Phase 2
N=147
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Cholangiocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02924376 ↗Enrolled (actual)
147
Serious AEs
46.3%
Results posted
Feb 2023
Primary outcome: Primary: Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions — 37.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pemigatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions |
37.0 | — |
| SECONDARY ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions |
0.0 | — |
| SECONDARY ORR in All Participants With FGF/FGFR Alterations |
31.3 | — |
| SECONDARY ORR in Participants Negative for FGF/FGFR Alterations |
0.0 | — |
| SECONDARY Progression-free Survival (PFS) |
7.03; 2.10; 1.51 | — |
| SECONDARY Duration of Response (DOR) |
9.13 | — |
| SECONDARY Disease Control Rate (DCR) |
82.4; 40.0; 17.6 | — |
| SECONDARY Overall Survival |
17.48; 6.70; 3.98 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
108; 20; 17; 2 | — |
| SECONDARY First-order Absorption Rate Constant (ka) of Pemigatinib |
1.29 | — |
| SECONDARY CL/F of Pemigatinib |
12.2 | — |
| SECONDARY Vc/F of Pemigatinib |
144 | — |
| SECONDARY Vp/F of Pemigatinib |
85.6 | — |
Summary
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed cholangiocarcinoma.
- Radiographically measurable or evaluable disease per RECIST v1.1.
- Tumor assessment for FGF/FGFR gene alteration status.
- Documented disease progression after at least 1 line of prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy ≥ 12 weeks.
Exclusion Criteria
- Prior receipt of a selective FGFR inhibitor.
- History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
- Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
- Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
Data sourced from ClinicalTrials.gov (NCT02924376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.