18 and older, any sex, with FGFR1 Gene Amplification or FGFR1 Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· 4.4 Months
Defined as the rate of patients, among evaluable patients, who experience an objective response per RECIST 1.1. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson.
Group
Value
95% CI
Treatment (Pemigatinib)
0.0
0.0 – 0.232
Clinical Benefit RateSecondary· 4.4 Months
Clinical Benefit Rate is defined as the number of patients that experience a complete or partial response, or have stable disease, divided by the number of evaluable patients. Analysis of this endpoint will mirror that of the primary objective.
Progression-free survival (PFS) is defined as the time from study entry to the first of either disease progression or death from any cause, where disease progression is determined based on RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and corresponding 95% confidence interval will be reported. Patients who do not experience disease progression or death while on protocol will be censored at the last disease assessment date.
Group
Value
95% CI
Treatment (Pemigatinib)
9.1
7.9 – NA
Overall Survival (OS)Secondary· 29.4 Months
Overall survival (OS) is defined as the time from study entry to death from any cause. Will be estimated using the Kaplan-Meier method. The median OS and corresponding 95% confidence interval will be reported.
Group
Value
95% CI
Treatment (Pemigatinib)
7.9
3.4 – NA
Quality of Life (QOL) as Measured by the LASA [Item 1: Overall QOL]Secondary· 9 Months
Quality of Life (QOL) was measured using item 1: Overall QOL of the Linear Analogue Self-Assessment (LASA) Questionnaire on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to Week 36 will be calculated by subtracting the baseline scores from the scores at Week 36. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.
Group
Value
95% CI
Treatment (Pemigatinib)
-0.1
± 1.22
Incidence of Adverse EventsSecondary· 5.4 Months
Adverse events will be summarized by frequency and severity using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in the adverse event section of this report. The number of patients evaluated for adverse events is reported below.
Group
Value
95% CI
Treatment (Pemigatinib)
14
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were followed for 5.4 months and mortality was followed for 29.4 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Pemigatinib)
Serious: 6/14 (43%)
Deaths: 11/14
Serious adverse events (9 terms)
Reaction
System
Treatment (Pemigatinib)
Nausea
Gastrointestinal disorders
—
Small intestinal obstruction
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Fatigue
General disorders
—
Pain
General disorders
—
Lung infection
Infections and infestations
—
Neoplasms benign, mal, uncpec - Oth spec
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06906562 — A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metasta
· Phase 2
· recruiting
NCT06653777 — Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells
· Phase 2
· recruiting
NCT06439485 — Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarc
· Phase 1, PHASE2
· recruiting
NCT06551896 — Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor
· Phase 2
· not yet recruiting
NCT06389799 — A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)
· Phase 2
· recruiting
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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 Academic and Community Cancer Research United
Last refreshed: 21 February 2024
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/NCT04096417.