Trial · NCT02616393
Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases
NCT02616393, Phase 2, Completed, Kadmon Corporation, LLC; results first posted 2021-11-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases. Trials, record NCT02616393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02616393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases
- NCT number
- NCT02616393
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- Non-Small Cell Lung Cancer, Leptomeningeal Metastases, Brain Metastases
- Interventions
- Tesevatinib
- First posted
- 2015-11-26
- Last updated
- 2022-03-16
- Results first posted
- 2021-11-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate (ORR) of Subjects With BM | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | The best overall response rates (ORRs) of subjects who had brain tumors and exhibited either a complete response (CR) or a partial responder (PR) to therapy divided by the total number of subjects treated with tesevatinib 300 mg PO QD. Response rates are in accordance with RECIST Version 1.1 criteria. Since such brain metastases (BM) tumors can either affect the central nervous system (CNS) or not affect the CNS (non-CNS), they were categorized into CNS and non-CNS subsets. Because leptomeningeal metastases (LM) only are considered cancer cell migration from the breast, lung, or some other part of the body to the cerebrospinal fluid (CSF), analysis of CNS are not appropriate, so Cohort B is excluded. |
| Primary | Best ORR of Subjects With LM | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | The best overall response rates (ORRs) of subjects who had leptomeningeal tumors and exhibited either a complete response (CR) or a partial responder (PR) to therapy divided by the total number of subjects treated with tesevatinib 300 mg PO QD. Response rates are in accordance with RECIST Version 1.1 criteria. Since leptomeningeal metastases (LM) are only considered cancer cell migration from the breast, lung, or some other part of the body to the cerebrospinal fluid (CSF), analysis of CNS are not appropriate, so Cohorts A and C are excluded. |
| Secondary | Median Progression-free Survival (PFS) | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | Median duration of survival without progression of subjects treated with tesevatinib 300 mg PO QD. |
| Secondary | Probability of PFS at 12 Weeks and 24 Weeks--Cohort A (BM Only) and Cohort B (LM Only) | 24 weeks (6 months) | Probability that subjects with brain metastases (BM) or leptomeningeal metastases (LM) would not progress, i.e., progression-free survival (PFS) after 12 weeks (3 months) and after 24 weeks (6 months) of treatment with tesevatinib 300 mg PO QD |
| Secondary | Probability of PFS at 24 Weeks--Cohort C (BM-IP Only) | 24 weeks (6 months) | Probability that subjects with brain metastases at initial presentation (BM-IP) would not progress, i.e., progression-free survival (PFS) after 24 weeks (6 months) of treatment with tesevatinib 300 mg PO QD |
| Secondary | Probability of OS at 12 Weeks and at 24 Weeks--Cohort A (BM Only) and Cohort B (LM Only) | 24 weeks (6 months) | Probability that subjects with brain metastases (BM) or leptomeningeal metastases (LM) survived (overall survival \[OS\]) after 12 weeks (3 months) and after 24 weeks (6 months) of treatment with tesevatinib 300 mg PO QD |
| Secondary | Median Time to Progression (TTP)--Cohort A (BM), Cohort B (LM), Cohort C (BM-IP) | Until disease progression, death, unacceptable toxicity, or up to 2 years, whichever occurred first | Median time to the development of disease progression (TTP) for subjects in Cohort A, Cohort B and Cohort C who were treated with tesevatinib 300 mg PO QD |
| Secondary | Probability of TTP at 12 Weeks and 24 Weeks--Non-CNS Cohort A (BM Only) and Cohort B (LM Only) | 24 weeks (6 months) | Probability that the time to progression (TTP) for subjects with no metastases to the central nervous system (non-CNS) in Cohort A (brain metastases only) or Cohort B (leptomeningeal metastases only) would be at 12 weeks (3 months) and at 24 weeks (6 months) of therapy with tesevatinib 300 mg PO QD. There were an insufficient number of subjects in Cohort C (brain metastases at initial presentation) who had events. |
| Secondary | Probability of TTP at 24 Weeks--CNS | 24 weeks (6 months) | Probability that the time to progression (TTP) for subjects with metastases to the central nervous system (CNS) would be at 24 weeks (6 months) of therapy with tesevatinib 300 mg PO QD. |
| Secondary | Quality of Life (QoL): Mean Change From Baseline in EORTC-QLQ-C30 Questionnaire Scores | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cancer 30 (C30) is a 30-question assessment composed of both multi-item scales and single-item measures: 5 functional scales, 3 symptom scales, 1 global QoL scale, and 6 single items. Ratings are on a 4-point scale (not at all, a little quite a bit, very much), with scoring from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. The outcome measure is the mean change in the EORTC-QLQ-C30 from baseline to a visit. |
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 | Best Overall Response Rate (ORR) of Subjects With BM | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | Subjects with BM only (Cohorts A and C). Subjects with LM (Cohort B) were excluded. | Percentage of participants (%) | NUMBER |
| PRIMARY | Best ORR of Subjects With LM | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | Percentage of participants (%) | NUMBER | |
| SECONDARY | Median Progression-free Survival (PFS) | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | Weeks | MEDIAN | |
| SECONDARY | Probability of PFS at 12 Weeks and 24 Weeks--Cohort A (BM Only) and Cohort B (LM Only) | 24 weeks (6 months) | Note: Cohort C (BM-IP) did not have a sufficient number of subjects with events to determine the PFS at 12 or 24 weeks. | Probability | NUMBER |
| SECONDARY | Probability of PFS at 24 Weeks--Cohort C (BM-IP Only) | 24 weeks (6 months) | Note: Insufficient data for PFS probability at 12 weeks | Probability | NUMBER |
| SECONDARY | Probability of OS at 12 Weeks and at 24 Weeks--Cohort A (BM Only) and Cohort B (LM Only) | 24 weeks (6 months) | Note: Cohort C did not have a sufficient number of subjects with events to determine the probability of survival at 12 or 24 weeks. | Probability | NUMBER |
| SECONDARY | Median Time to Progression (TTP)--Cohort A (BM), Cohort B (LM), Cohort C (BM-IP) | Until disease progression, death, unacceptable toxicity, or up to 2 years, whichever occurred first | Weeks | MEDIAN | |
| SECONDARY | Probability of TTP at 12 Weeks and 24 Weeks--Non-CNS Cohort A (BM Only) and Cohort B (LM Only) | 24 weeks (6 months) | Note: Cohort C (BM-IP) did not have a sufficient number of subjects with events to determine the probability of TTP at 12 weeks or 24 weeks. | Probability | NUMBER |
| SECONDARY | Probability of TTP at 24 Weeks--CNS | 24 weeks (6 months) | Probability | NUMBER | |
| SECONDARY | Quality of Life (QoL): Mean Change From Baseline in EORTC-QLQ-C30 Questionnaire Scores | Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred first | Note: Not all subjects were available for analysis at all visits. | Score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate (ORR) of Subjects With BM | Cohort A (BM) | CNS | 15.4 | 95% Confidence Interval 2 to 45 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Cohort C (BM-IP) | CNS | 100 | 95% Confidence Interval 29 to 100 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Overall BM | CNS | 31.3 | 95% Confidence Interval 11 to 59 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Cohort A (BM) | non-CNS | 0 | 95% Confidence Interval 0 to 25 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Cohort C (BM-IP) | non-CNS | 100 | 95% Confidence Interval 29 to 100 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Overall BM | non-CNS | 18.8 | 95% Confidence Interval 4 to 46 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Cohort A (BM) | CNS + non-CNS | 15.4 | 95% Confidence Interval 2 to 45 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Cohort C (BM-IP) | CNS + non-CNS | 100 | 95% Confidence Interval 29 to 100 | Percentage of participants (%) |
| Best Overall Response Rate (ORR) of Subjects With BM | Overall BM | CNS + non-CNS | 31.3 | 95% Confidence Interval 11 to 59 | Percentage of participants (%) |
| Best ORR of Subjects With LM | Cohort B (LM) | 0 | Percentage of participants (%) |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A (BM) | 13 | |
| Overall Study | STARTED | Cohort B (LM) | 20 | |
| Overall Study | STARTED | Cohort C (BM-IP) | 3 | |
| Overall Study | COMPLETED | Cohort A (BM) | 0 | |
| Overall Study | COMPLETED | Cohort B (LM) | 0 | |
| Overall Study | COMPLETED | Cohort C (BM-IP) | 0 | |
| Overall Study | NOT COMPLETED | Cohort A (BM) | 13 | |
| Overall Study | NOT COMPLETED | Cohort B (LM) | 20 | |
| Overall Study | NOT COMPLETED | Cohort C (BM-IP) | 3 |
Source ClinicalTrials.gov
Adverse events428
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 | Cohort A - Brain Metastases | 10 | 13 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort B - Leptomeningeal Metastases | 14 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort C - Brain Metastases at Initial Presentation | 0 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | All Subjects (Cohorts A+B+C) | 24 | 36 | |
| other | Fatigue | General disorders | Cohort A - Brain Metastases | 5 | 13 | |
| other | Fatigue | General disorders | Cohort B - Leptomeningeal Metastases | 8 | 20 | |
| other | Fatigue | General disorders | Cohort C - Brain Metastases at Initial Presentation | 3 | 3 | |
| other | Fatigue | General disorders | All Subjects (Cohorts A+B+C) | 16 | 36 | |
| other | QT Prolongation | Investigations | Cohort A - Brain Metastases | 5 | 13 | |
| other | QT Prolongation | Investigations | Cohort B - Leptomeningeal Metastases | 9 | 20 |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A - Brain Metastases | 5 | 13 |
| Total, all-cause mortality | Cohort B - Leptomeningeal Metastases | 12 | 20 |
| Total, all-cause mortality | Cohort C - Brain Metastases at Initial Presentation | 1 | 3 |
| Total, all-cause mortality | All Subjects (Cohorts A+B+C) | 18 | 36 |
| Total, other adverse events | Cohort A - Brain Metastases | 13 | 13 |
| Total, other adverse events | Cohort B - Leptomeningeal Metastases | 20 | 20 |
| Total, other adverse events | Cohort C - Brain Metastases at Initial Presentation | 3 | 3 |
| Total, other adverse events | All Subjects (Cohorts A+B+C) | 36 | 36 |
| Total, serious adverse events | Cohort A - Brain Metastases | 6 | 13 |
| Total, serious adverse events | Cohort B - Leptomeningeal Metastases | 13 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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