FIGHT-207
Research type
Research Study
Full title
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
IRAS ID
265415
Contact name
Janet Noerenberg
Contact email
Sponsor organisation
Incyte
Eudract number
2018-004768-69
Duration of Study in the UK
1 years, 4 months, 18 days
Research summary
This phase 2 (researcher know that the treatment is safe to use, first side effects are known and how the body gets rid of the drug and that it has an effect on cancer cells), open label (researcher and patient know the treatment for the patient) study for patients over 18years, is to evaluate the efficacy of pemigatinib in patients whom have tumour cells in local lymph nodes, in different organs/ organ systems or surgically unresectable solid tumour malignancy that can't be removed. It is required these tumour cells show an activating FGFR (Fibroblast Growth Factor Receptor, a human protein) mutation or translocation. For that tumour cells will be tested before a patient will be treated in the study, which requires a biopsy or archived tumour samples. Another key point is that patients have currently no known therapy available as their cancer has progressed under former therapies. Regarding to their FGFR mutation/ translocation the patients will join one of three cohorts, which has no treatment effect, it is just needed for data management. After 3 month all patients have an imaging, to evaluate if the tumour is bigger or responded on the treatment. The study doctor will then on decide if there will be further pemigatinib treatment and how long the period with imaging all 9 weeks will be. There is a possibility to provide more tumour samples during the study but it is definitely required after ending of study treatment so the researcher can evaluate how the tumour has changed with pemigatinib treatment.
Summary of study results:
Pemigatinib showed activity across a variety of solid tumors. The ORR for participants in Cohort A was 26.5% and in Cohort B was 9.4%; responses were observed in participants with cholangiocarcinoma (8 PRs), glioblastoma (1 CR and 1 PR), pancreatic cancer (3 PRs), cervical cancer (2 PRs), and urothelial cancer (1 PR). The study was terminated by the sponsor due to reasons unrelated to efficacy or safety concerns.
REC name
London - South East Research Ethics Committee
REC reference
19/LO/1152
Date of REC Opinion
24 Jul 2019
REC opinion
Favourable Opinion