Trial · NCT02844439
Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma
NCT02844439, Phase 2, Completed, Kadmon Corporation, LLC; results first posted 2021-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma. Trials, record NCT02844439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02844439
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma
- NCT number
- NCT02844439
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Glioblastoma, Recurrent Glioblastoma, Brain Tumor
- Interventions
- Tesevatinib
- First posted
- 2016-07-26
- Last updated
- 2021-09-22
- Results first posted
- 2021-09-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6) | 6 months | Proportion (%) of subjects who did not have progressive disease after treatment with tesevatinib at 6 months (PFS-6) after baseline |
| Secondary | Efficacy: Median PFS | Until disease progression, unacceptable toxicity, subject or clinician decision to discontinue, death, or up to 3 years, whichever occurred first | Median duration (months) of subjects who were progression-free of disease from baseline |
| Secondary | Efficacy: Median Overall Survival Rate at 9 Months (OS-9) | 9 months | Median proportion (%) of subjects who survived 9 months after baseline |
| Secondary | Efficacy: Median OS | Until unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first | Median duration (months) subjects survived from baseline until death |
| Secondary | Efficacy: Best Overall Response | Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first | Best overall response that subjects had to treatment with tesevatinib: complete response (CR), partial response (PR), stable disease (SD), or non-response/progressive disease (PD) |
| Secondary | Efficacy: Objective Response Rate (ORR) | Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or 3 years, whichever occurred first | Proportion (%) of subjects who had either a complete response (CR) or a partial response (PR) to treatment with tesevatinib |
| Secondary | Exposure to Tesevatinib: Overall Mean | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first | Mean total amount of tesevatinib (mg) subjects received during the study |
| Secondary | Exposure to Tesevatinib: Overall Median | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first | Median amount of tesevatinib (mg) subjects received during the study |
| Secondary | Exposure to Tesevatinib: Mean Number of Cycles | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first. | Mean number of 28-day cycles of treatment with tesevatinib subjects received during the study |
| Secondary | Exposure to Tesevatinib: Median Number of Cycles | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first | Median number of 28-day cycles of treatment with tesevatinib subjects received during the study |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6) | 6 months | Percentage (%) of subjects | NUMBER | |
| SECONDARY | Efficacy: Median PFS | Until disease progression, unacceptable toxicity, subject or clinician decision to discontinue, death, or up to 3 years, whichever occurred first | Months | MEDIAN | |
| SECONDARY | Efficacy: Median Overall Survival Rate at 9 Months (OS-9) | 9 months | Percentage (%) of subjects | NUMBER | |
| SECONDARY | Efficacy: Median OS | Until unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first | Months | MEDIAN | |
| SECONDARY | Efficacy: Best Overall Response | Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first | Note: NA = data not available; NE = not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Objective Response Rate (ORR) | Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or 3 years, whichever occurred first | Percentage (%) of participants | NUMBER | |
| SECONDARY | Exposure to Tesevatinib: Overall Mean | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first | mg (tesevatinib) | MEAN | |
| SECONDARY | Exposure to Tesevatinib: Overall Median | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first | mg (tesevatinib) | MEDIAN | |
| SECONDARY | Exposure to Tesevatinib: Mean Number of Cycles | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first. | Number of cycles | MEAN | |
| SECONDARY | Exposure to Tesevatinib: Median Number of Cycles | Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first | Number of cycles | MEDIAN |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6) | Total | 22.5 | 95% Confidence Interval 10.8 to 38.5 | Percentage (%) of subjects | |
| Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6) | Sub-population A | 25.0 | 95% Confidence Interval 9.8 to 46.7 | Percentage (%) of subjects | |
| Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6) | Sub-population B | 18.2 | 95% Confidence Interval 2.3 to 51.8 | Percentage (%) of subjects | |
| Efficacy: Median PFS | Total | 2.3 | 95% Confidence Interval 1.08 to 2.96 | Months | |
| Efficacy: Median PFS | Sub-population A | 1.7 | 95% Confidence Interval 0.95 to 2.96 | Months | |
| Efficacy: Median PFS | Sub-population B | 1.0 | 95% Confidence Interval 0.92 to 4.93 | Months | |
| Efficacy: Median Overall Survival Rate at 9 Months (OS-9) | Total | 42.5 | 95% Confidence Interval 27.0 to 59.1 | Percentage (%) of subjects | |
| Efficacy: Median Overall Survival Rate at 9 Months (OS-9) | Sub-population A | 37.5 | 95% Confidence Interval 18.8 to 59.4 | Percentage (%) of subjects | |
| Efficacy: Median Overall Survival Rate at 9 Months (OS-9) | Sub-population B | 27.3 | 95% Confidence Interval 6.0 to 61.0 | Percentage (%) of subjects | |
| Efficacy: Median OS | Total | 8.4 | 95% Confidence Interval 7.36 to 12.29 | Months |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total | 40 | |
| Overall Study | Subpopulation A (EGFR Gene Amplified Glioblastoma) | Total | 24 | |
| Overall Study | Subpopulation B (EGFRvIII^Pos Glioblastoma) | Total | 11 | |
| Overall Study | COMPLETED | Total | 0 | |
| Overall Study | NOT COMPLETED | Total | 40 |
Source ClinicalTrials.gov
Adverse events219
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 | Diarrhea | Gastrointestinal disorders | Total | 31 | 40 | |
| other | Diarrhea | Gastrointestinal disorders | Sub-population A | 20 | 24 | |
| other | Diarrhea | Gastrointestinal disorders | Sub-population B | 11 | 11 | |
| other | Nausea | Gastrointestinal disorders | Total | 6 | 40 | |
| other | Nausea | Gastrointestinal disorders | Sub-population A | 3 | 24 | |
| other | Nausea | Gastrointestinal disorders | Sub-population B | 2 | 11 | |
| other | Abdominal pain | Gastrointestinal disorders | Total | 3 | 40 | |
| other | Abdominal pain | Gastrointestinal disorders | Sub-population A | 2 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | Sub-population B | 1 | 11 | |
| other | GERD | Gastrointestinal disorders | Total | 3 | 40 |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total | 28 | 40 |
| Total, all-cause mortality | Sub-population A | 19 | 24 |
| Total, all-cause mortality | Sub-population B | 9 | 11 |
| Total, other adverse events | Total | 40 | 40 |
| Total, other adverse events | Sub-population A | 24 | 24 |
| Total, other adverse events | Sub-population B | 11 | 11 |
| Total, serious adverse events | Total | 12 | 40 |
| Total, serious adverse events | Sub-population A | 7 | 24 |
| Total, serious adverse events | Sub-population B | 2 | 11 |
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 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/NCT02844439
GET https://conductscience.org/api/trials/v1/NCT02844439/results?page=2