Trial · NCT05267106
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
NCT05267106, Phase 2, Terminated, Incyte Corporation; results first posted 2025-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations. Trials, record NCT05267106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05267106
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
- NCT number
- NCT05267106
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Glioblastoma, Adult-type Diffuse Gliomas
- Interventions
- Pemigatinib
- First posted
- 2022-03-04
- Last updated
- 2025-12-30
- Other registries' IDs
- eudract:2021-004740-24
- Results first posted
- 2025-12-30
- Limitations and caveats
- The study was terminated by the sponsor after the prespecified interim analysis did not meet the futility boundary.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review | up to 651 days | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) as determined by an independent centralized radiological review committee. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically. |
| Secondary | ORR in Participants With Recurrent Non-glioblastoma Central Nervous System Tumors Based on Independent Central Review | up to 784 days | ORR was defined as the percentage of participants who achieved a best overall response of CR or PR based on RANO as determined by an independent centralized radiological review committee. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically. |
| Secondary | Duration of Confirmed Response Based on Independent Central Review | up to 784 days | Duration of response was defined as the time from the first assessment of confirmed CR or PR until progressive disease (PD) (according to RANO and assessed by an independent centralized radiological review committee) or death (whichever occurred first). Progression was defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose. |
| Secondary | Duration of Unconfirmed Response Based on Independent Central Review | up to 784 days | Duration of response was defined as the time from the first assessment of unconfirmed CR or PR until progressive disease (PD) (according to RANO and assessed by an independent centralized radiological review committee) or death (whichever occurred first). Progression was defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose. |
| Secondary | ORR as Determined by Investigator Assessment | up to 784 days | ORR was defined as the percentage of participants who achieved an unconfirmed best overall response of CR or PR based on RANO as determined by investigator assessment. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 814 days | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. |
| Secondary | Number of Participants With Any ≥Grade 3 TEAE | up to 814 days | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
| Secondary | Number of Participants With TEAEs Leading to Discontinuation of Pemigatinib, Pemigatinib Dose Interruption, and Pemigatinib Dose Reduction | up to 814 days | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. |
| Secondary | Disease Control Rate (DCR) Based on Independent Central Review | up to 784 days | DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) based on RANO as determined by an independent centralized radiological review committee. In the case of SD, measurements must have met the SD criteria after the date of the first dose at a minimum interval of 42 days. SD occurred if the participant didn't qualify for CR, PR, or PD and required the following: stable nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan and clinically stable status. |
| Secondary | Progression-free Survival (PFS) Based on Independent Central Review | up to 784 days | PFS was defined as the time from the first dose until progressive disease (according to RANO and assessed by an independent centralized radiological review committee) or death (whichever occurred first). Progression was defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review | up to 651 days | Full Analysis Set: all enrolled participants who received at least 1 dose of pemigatinib. The 95% confidence interval (CI) was calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | ORR in Participants With Recurrent Non-glioblastoma Central Nervous System Tumors Based on Independent Central Review | up to 784 days | Full Analysis Set. The 95% CI was calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Duration of Confirmed Response Based on Independent Central Review | up to 784 days | Full Analysis Set. Only those participants with a confirmed CR or PR were analyzed. The 95% CIs were calculated using the Brookmeyer and Crowley method. | months | MEDIAN |
| SECONDARY | Duration of Unconfirmed Response Based on Independent Central Review | up to 784 days | Full Analysis Set. Only those participants with an unconfirmed CR or PR were analyzed. The 95% CIs were calculated using the Brookmeyer and Crowley method. | months | MEDIAN |
| SECONDARY | ORR as Determined by Investigator Assessment | up to 784 days | Full Analysis Set. The 95% CIs were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 814 days | Safety Population: all enrolled participants who received at least 1 dose of pemigatinib | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any ≥Grade 3 TEAE | up to 814 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs Leading to Discontinuation of Pemigatinib, Pemigatinib Dose Interruption, and Pemigatinib Dose Reduction | up to 814 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) Based on Independent Central Review | up to 784 days | Full Analysis Set. The 95% CIs were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Based on Independent Central Review | up to 784 days | Full Analysis Set. The 95% CIs were calculated using the Brookmeyer and Crowley method. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review | Recurrent Glioblastoma | Confirmed tumor responses | 5.4 | 95% Confidence Interval 1.49 to 13.27 | percentage of participants |
| Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review | Recurrent Glioblastoma | Unconfirmed tumor responses | 8.1 | 95% Confidence Interval 3.03 to 16.82 | percentage of participants |
| ORR in Participants With Recurrent Non-glioblastoma Central Nervous System Tumors Based on Independent Central Review | Recurrent Non-glioblastoma CNS Tumors | Confirmed tumor responses | 22.2 | 95% Confidence Interval 2.81 to 60.01 | percentage of participants |
| ORR in Participants With Recurrent Non-glioblastoma Central Nervous System Tumors Based on Independent Central Review | Recurrent Non-glioblastoma CNS Tumors | Unconfirmed tumor responses | 22.2 | 95% Confidence Interval 2.81 to 60.01 | percentage of participants |
| Duration of Confirmed Response Based on Independent Central Review | Recurrent Glioblastoma | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Confirmed Response Based on Independent Central Review | Recurrent Non-glioblastoma CNS Tumors | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Unconfirmed Response Based on Independent Central Review | Recurrent Glioblastoma | NA | 95% Confidence Interval 1.74 to NA | months | |
| Duration of Unconfirmed Response Based on Independent Central Review | Recurrent Non-glioblastoma CNS Tumors | NA | 95% Confidence Interval NA to NA | months | |
| ORR as Determined by Investigator Assessment | Recurrent Glioblastoma | 8.1 | 95% Confidence Interval 3.03 to 16.82 | percentage of participants | |
| ORR as Determined by Investigator Assessment | Recurrent Non-glioblastoma CNS Tumors | 22.2 | 95% Confidence Interval 2.81 to 60.01 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recurrent Glioblastoma | 74 | |
| Overall Study | STARTED | Recurrent Non-glioblastoma CNS Tumors | 9 | |
| Overall Study | COMPLETED | Recurrent Glioblastoma | 0 | |
| Overall Study | COMPLETED | Recurrent Non-glioblastoma CNS Tumors | 0 | |
| Overall Study | NOT COMPLETED | Recurrent Glioblastoma | 74 | |
| Overall Study | NOT COMPLETED | Recurrent Non-glioblastoma CNS Tumors | 9 |
Source ClinicalTrials.gov
Adverse events381
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 discomfort | Gastrointestinal disorders | Recurrent Glioblastoma | 0 | 74 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Recurrent Non-glioblastoma CNS Tumors | 1 | 9 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Total | 1 | 83 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Recurrent Glioblastoma | 5 | 74 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Recurrent Non-glioblastoma CNS Tumors | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Total | 6 | 83 | 8 |
| other | Alanine aminotransferase increased | Investigations | Recurrent Glioblastoma | 12 | 74 | 15 |
| other | Alanine aminotransferase increased | Investigations | Recurrent Non-glioblastoma CNS Tumors | 2 | 9 | 3 |
| other | Alanine aminotransferase increased | Investigations | Total | 14 | 83 | 18 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Recurrent Glioblastoma | 16 | 74 | 16 |
1 to 10 of 381Source ClinicalTrials.gov
See all 381 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recurrent Glioblastoma | 50 | 74 |
| Total, all-cause mortality | Recurrent Non-glioblastoma CNS Tumors | 2 | 9 |
| Total, all-cause mortality | Total | 52 | 83 |
| Total, other adverse events | Recurrent Glioblastoma | 71 | 74 |
| Total, other adverse events | Recurrent Non-glioblastoma CNS Tumors | 9 | 9 |
| Total, other adverse events | Total | 80 | 83 |
| Total, serious adverse events | Recurrent Glioblastoma | 17 | 74 |
| Total, serious adverse events | Recurrent Non-glioblastoma CNS Tumors | 0 | 9 |
| Total, serious adverse events | Total | 17 | 83 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Recurrent Glioblastoma vs Recurrent Non-glioblastoma CNS Tumors: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Recurrent Glioblastoma vs Recurrent Non-glioblastoma CNS Tumors: Number of Participants With Any ≥Grade 3 TEAE | Trial comparisons |
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/NCT05267106
GET https://conductscience.org/api/trials/v1/NCT05267106/results?page=2