Trial · NCT03011372
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
NCT03011372, Phase 2, Completed, Incyte Corporation; results first posted 2025-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203). Trials, record NCT03011372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03011372
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
- NCT number
- NCT03011372
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- MPN (Myeloproliferative Neoplasms)
- Interventions
- Pemigatinib
- First posted
- 2017-01-05
- Last updated
- 2025-11-18
- Other registries' IDs
- eudract:2016-002596-10
- Results first posted
- 2025-11-18
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | up to 2513 days (120 21-day treatment cycles) | CR was defined as the presence of all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (Grade 1 or less fibrosis); (3) peripheral blood: white blood cells (WBC) ≤10 x 10\^9 cells/Liter (L); hemoglobin (Hgb) ≥11 grams per deciliter (g/dL); platelets ≥100 x 10\^9/L and ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts = 0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present before therapy (e.g., lymphadenopathy), including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted given subjectivity of assignment of dysplasia. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP). |
| Secondary | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | up to 2513 days (120 21-day treatment cycles) | CR=all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent/equal to "mild reticulin fibrosis"; (3) WBC ≤10 x 10\^9 cells/L; Hgb ≥11 g/dL; platelets ≥100 x 10\^9/L, ≤450 x 10\^9/L; neutrophils ≥1.0 x 10\^9/L; blasts=0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10\^9/L; eosinophils ≤0.5 x 10\^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present pre-therapy, including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted. PR=all of the following improvements: (1) reduction of bone marrow blasts/blast equivalents by 50%, but remaining \>5% of cellularity (except in cases with ≤5% bone marrow blasts at baseline); (2) normalization of peripheral blood indices per CR Criterion 3; (3) extra medullary disease response of CMR/CR or PMR/PR. |
| Secondary | Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation | up to 2513 days (120 21-day treatment cycles) | CCyR was defined as 0% 8p11 translocated metaphases as seen on classic karyotyping with minimal of 20 metaphases, or fluorescence in situ hybridization (FISH). Loss of cytogenetic burden of disease (via FISH or classic karyotyping) was required to reach CCyR. |
| Secondary | Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation | up to 2513 days (120 21-day treatment cycles) | PCyR was defined as the decrease from baseline of 50% or more 8p11 translocated metaphases as seen on classic karyotyping with minimal of 20 metaphases, or FISH. |
| Secondary | Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. |
| Secondary | Duration of Complete Response | up to 2513 days (120 21-day treatment cycles) | Duration of complete response was defined as the time from the first assessment of complete response to the earlier of the date of first worsening assessment after complete response or death due to any cause |
| Secondary | Duration of Response | up to 2513 days (120 21-day treatment cycles) | Duration of response was defined as the time from the first assessment of complete response or partial response to the earlier of the date of first worsening assessment after response or death due to any cause. |
| Secondary | Progression-free Survival (PFS) | up to 2513 days (120 21-day treatment cycles) | PFS was defined as the time from the first date of taking study drug until the date of disease progression or until death due to any cause, whichever was earlier. Disease progression was defined as the combination of 2 major criteria, 1 major and 2 minor criteria, or 3 minor criteria from the following lists. Major criteria: (1) increase in blast count; (2) evidence of cytogenetic evolution (re-appearance of a previously present or appearance of a new cytogenetic abnormality, or increase in cytogenetic burden of disease); (3) new or worsening extramedullary disease (worsening splenomegaly or extramedullary disease outside of the spleen). Minor criteria: (1) transfusion dependence; (2) significant loss of maximal response on cytopenias ≥50% decrement from maximum remission/response in granulocytes or platelets; (3) reduction in Hgb by ≥1.5g/dL from best response or from baseline as noted on complete blood count; (4) evidence of clonal evolution (molecular). |
| Secondary | Overall Survival | up to 2513 days (120 21-day treatment cycles) | Overall survival was defined as as the time from the first day of taking study drug until death due to any cause |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 2543 days | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population: all enrolled participants with an FGFR1 rearrangement and who received at least 1 dose of study drug. For this report, the full EEP included both previously treated and treatment-naive participants. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Achieved CR as Determined by Central Review Committee (CRC) Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. CMR=complete metabolic response; PMR=partial metabolic response. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP). | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Achieved a Best Overall Response of CR or PR as Determined by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Achieved a CCyR as Assessed by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Duration of Complete Response | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Only participants with a complete response were analyzed. Confidence intervals were calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
| SECONDARY | Duration of Response | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Only participants with complete response or partial response were analyzed. Confidence intervals were calculated based on the exact method for binomial distribution. | months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | Pemigatinib 13.5 mg | 68.9 | 95% Confidence Interval 53.35 to 81.83 | percentage of participants | |
| Percentage of Participants Who Achieved CR as Determined by Central Review Committee (CRC) Assessment | Pemigatinib 13.5 mg | 68.9 | 95% Confidence Interval 53.35 to 81.83 | percentage of participants | |
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | Pemigatinib 13.5 mg | 77.8 | 95% Confidence Interval 62.91 to 88.80 | percentage of participants | |
| Percentage of Participants Who Achieved a Best Overall Response of CR or PR as Determined by CRC Assessment | Pemigatinib 13.5 mg | 75.6 | 95% Confidence Interval 60.46 to 87.12 | percentage of participants | |
| Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation | Pemigatinib 13.5 mg | 73.3 | 95% Confidence Interval 58.06 to 85.40 | percentage of participants | |
| Percentage of Participants Who Achieved a CCyR as Assessed by CRC Assessment | Pemigatinib 13.5 mg | 73.3 | 95% Confidence Interval 58.06 to 85.40 | percentage of participants | |
| Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation | Pemigatinib 13.5 mg | 8.9 | 95% Confidence Interval 2.48 to 21.22 | percentage of participants | |
| Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment | Pemigatinib 13.5 mg | 15.6 | 95% Confidence Interval 6.49 to 29.46 | percentage of participants | |
| Duration of Complete Response | Pemigatinib 13.5 mg | Investigator assessment | 53.29 | 95% Confidence Interval 12.22 to NA | months |
| Duration of Complete Response | Pemigatinib 13.5 mg | CRC assessment | NA | 95% Confidence Interval 27.86 to NA | months |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pemigatinib 13.5 mg | 47 | |
| Overall Study | COMPLETED | Pemigatinib 13.5 mg | 0 | |
| Overall Study | NOT COMPLETED | Pemigatinib 13.5 mg | 47 |
Source ClinicalTrials.gov
Adverse events190
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Pemigatinib 13.5 mg | 3 | 47 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Pemigatinib 13.5 mg | 16 | 47 | 25 |
| other | Abdominal pain upper | Gastrointestinal disorders | Pemigatinib 13.5 mg | 7 | 47 | 9 |
| other | Acute kidney injury | Renal and urinary disorders | Pemigatinib 13.5 mg | 3 | 47 | 5 |
| other | Ageusia | Nervous system disorders | Pemigatinib 13.5 mg | 6 | 47 | 7 |
| other | Alanine aminotransferase increased | Investigations | Pemigatinib 13.5 mg | 6 | 47 | 11 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pemigatinib 13.5 mg | 26 | 47 | 29 |
| other | Anaemia | Blood and lymphatic system disorders | Pemigatinib 13.5 mg | 16 | 47 | 27 |
| other | Anxiety | Psychiatric disorders | Pemigatinib 13.5 mg | 5 | 47 | 7 |
| other | Aphthous ulcer | Gastrointestinal disorders | Pemigatinib 13.5 mg | 3 | 47 | 3 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pemigatinib 13.5 mg | 16 | 47 |
| Total, other adverse events | Pemigatinib 13.5 mg | 46 | 47 |
| Total, serious adverse events | Pemigatinib 13.5 mg | 27 | 47 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03011372
GET https://conductscience.org/api/trials/v1/NCT03011372/events?page=2