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NCT04003623
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
Terminated
Phase 2
Results posted
Last updated 10 May 2022
What this trial tests
Phase 2 trial testing Pemigatinib in Advanced or Metastatic Solid Tumors in 1 participant. Terminated before completion.
Timeline
31 October 2019
Primary endpoint
12 June 2020
12 June 2020
12 June 2020
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 31 October 2019 |
| Primary completion | 12 June 2020 |
| Estimated completion | 12 June 2020 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- Pemigatinib (PEMIGATINIB) — full drug profile →
Conditions studied
- Advanced or Metastatic Solid Tumors — all drugs for Advanced or Metastatic Solid Tumors →
- FGFR Mutations — all drugs for FGFR Mutations →
- FGFR Translocations — all drugs for FGFR Translocations →
Sponsor
Incyte Corporation — full company profile →
Who can join
18 and older, any sex, with Advanced or Metastatic Solid Tumors or FGFR Mutations. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: May 2020 to June 2020. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements
Serious: 0/1 (0%)
Deaths: 0/1
Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3
Serious: 0
Deaths: 0
Other adverse events (6 terms — click to expand)
| Reaction | System | Cohort A: Participants Wit… | Cohort B: Participants Wit… |
|---|---|---|---|
| Blurred Vision | Eye disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — | — |
| Lower Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT04003623 adverse events section.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
FGFR-TKI resistance in cancer: current status and perspectives.
Yue S, Li Y, Chen X, Wang J, et al · · 2021 · cited 98× · PMID 33568192 · DOI 10.1186/s13045-021-01040-2 -
FGFR4: A promising therapeutic target for breast cancer and other solid tumors.
Levine KM, Ding K, Chen L, Oesterreich S. · · 2020 · cited 68× · PMID 32492514 · DOI 10.1016/j.pharmthera.2020.107590 -
Fibroblast growth factor receptor fusions in cancer: opportunities and challenges.
Chen L, Zhang Y, Yin L, Cai B, et al · · 2021 · cited 50× · PMID 34732230 · DOI 10.1186/s13046-021-02156-6 -
Dermatologic Adverse Events Associated with Selective Fibroblast Growth Factor Receptor Inhibitors: Overview, Prevention, and Management Guidelines.
Lacouture ME, Sibaud V, Anadkat MJ, Kaffenberger B, et al · · 2021 · cited 45× · PMID 33021006 · DOI 10.1002/onco.13552 -
Fibroblast growth factor (FGF), FGF receptor (FGFR), and cyclin D1 (CCND1) DNA methylation in head and neck squamous cell carcinomas is associated with transcriptional activity, gene amplification, human papillomavirus (HPV) status, and sensitivity to tyrosine kinase inhibitors.
Bao Y, Gabrielpillai J, Dietrich J, Zarbl R, et al · · 2021 · cited 21× · PMID 34933671 · DOI 10.1186/s13148-021-01212-4 -
Targeted Therapies in Advanced Cholangiocarcinoma: A Focus on FGFR Inhibitors.
Rizzo A. · · 2021 · cited 12× · PMID 34066684 · DOI 10.3390/medicina57050458 -
Recent advances in novel tumor immunotherapy strategies based on regulating the tumor microenvironment and immune checkpoints.
Jing H, Gao Y, Sun Z, Liu S. · · 2025 · cited 7× · PMID 40607438 · DOI 10.3389/fimmu.2025.1529403 -
Systemic Treatment for Metastatic Biliary Tract Cancer: State of the Art and a Glimpse to the Future.
Rizzo A, Ricci AD, Cusmai A, Acquafredda S, et al · · 2022 · cited 6× · PMID 35200550 · DOI 10.3390/curroncol29020050
Verify or expand the search:
- PubMed search for NCT04003623
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04003623 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
- Last refreshed: 10 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04003623.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing