Trial · NCT02154529
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
NCT02154529, Phase 1, Phase 2, Terminated, Kadmon Corporation, LLC; results first posted 2022-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer. Trials, record NCT02154529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02154529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
- NCT number
- NCT02154529
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Kadmon Corporation, LLC
- Conditions
- HER-2 Positive Breast Cancer, Metastatic Malignant Neoplasm to Brain
- Interventions
- Tesevatinib, Trastuzumab
- First posted
- 2014-06-03
- Last updated
- 2022-04-27
- Results first posted
- 2022-03-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-up | Percentage of subjects with at least 1 treatment-emergent adverse event of Grade 3 or greater or relationship with tesevatinib. TEAE grading was by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) where Grade 3 is severe and Grade 4 is life-threatening. TEAEs were considered related to study drug if the investigator assessed them as possibly related, probably related, or related. |
| Primary | Safety and Tolerability: Percentage of Subjects With Serious Adverse Event (SAE) Related to Tesevatinib | Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-up | Percentage of subjects with at least 1 serious adverse event considered related to study drug. SAEs were considered related to tesevatinib drug if the investigator assessed them as possibly related, probably related, or related. |
| Secondary | Pharmacokinetics (PK): Mean Serum Cmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | The mean of the maximum serum concentration (Cmax) for the combination of tesevatinib and trastuzumab after 1 cycle (Cycle 2 Day 1). |
| Secondary | Pharmacokinetics: Median Serum Tmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | The median time of the maximum serum concentration (Tmax) for the combination of tesevatinib and trastuzumab after 1 cycle (Cycle 2 Day 1) |
| Secondary | Pharmacokinetics: Mean Serum AUC(0-t) (Area Under Curve) of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | The mean area under the concentration-time curve during the period from 0 to a given time point 't' in the tesevatinib 150 mg QD, 250 mg QD, and 300 mg QD cohorts. |
| Secondary | Pharmacokinetics: Mean AR Cmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | The mean of the arithmetic mean accumulation ratio (AR) of the maximum concentration of tesevatinib. The AR is defined as: Cmax for Cycle 2 divided by Cmax of Cycle 1. |
| Secondary | Pharmacokinetics: Mean AR AUC(0-24hr) After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | The mean of the arithmetic mean accumulation ratio (AR) of the area under the concentration-time curve from 0 to 24 hours. The AR is defined as: AUC(0-24hr) for Cycle 2 divided by AUC(0-24hr) for Cycle 1. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-up | All subjects who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety and Tolerability: Percentage of Subjects With Serious Adverse Event (SAE) Related to Tesevatinib | Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-up | All subjects who received at last 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Mean Serum Cmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | Subjects who completed at least 1 cycle of study drug and had PK (pharmacokinetics) measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150 mg tesevatinib PO (by mouth) QD(once daily) / 6 mg/kg trastuzumab IV every 3 weeks. Note: Subjects in Cohort 350 mg tesevatinib received only 8 mg/kg trastuzumab and so were not included in this analysis. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics: Median Serum Tmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib received only 8 mg/kg trastuzumab and so were not included in this analysis. | hours | MEDIAN |
| SECONDARY | Pharmacokinetics: Mean Serum AUC(0-t) (Area Under Curve) of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib received 8 mg/kg trastuzumab and so were not included in this analysis. | hr*ng/mL | MEAN |
| SECONDARY | Pharmacokinetics: Mean AR Cmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib only received 8 mg/kg trastuzumab and so were not included in this analysis. | ratio (no units) | MEAN |
| SECONDARY | Pharmacokinetics: Mean AR AUC(0-24hr) After 1 Cycle of Treatment With Tesevatinib + Trastuzumab | PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 | Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib received only 8 mg/kg trastuzumab and so were not included in this analysis. | ratio (no units) | MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | Grade ≥ 3 | 1 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | Grade ≥ 3 | 1 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | Grade ≥ 3 | 5 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | Grade ≥ 3 | 2 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | All Patients | Grade ≥ 3 | 9 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | Related to Tesevatinib | 4 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | Related to Tesevatinib | 3 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | Related to Tesevatinib | 7 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | Related to Tesevatinib | 2 | Participants | |
| Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib | All Patients | Related to Tesevatinib | 16 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 4 | |
| Overall Study | STARTED | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 3 | |
| Overall Study | STARTED | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | 8 | |
| Overall Study | STARTED | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | 2 | |
| Overall Study | COMPLETED | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 0 | |
| Overall Study | COMPLETED | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 0 | |
| Overall Study | COMPLETED | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | 0 | |
| Overall Study | COMPLETED | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | 0 | |
| Overall Study | NOT COMPLETED | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 4 | |
| Overall Study | NOT COMPLETED | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events450
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 | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 3 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 2 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | 7 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | 2 | 2 | |
| other | Diarrhea | Gastrointestinal disorders | All Patients | 14 | 17 | |
| other | Nausea | Gastrointestinal disorders | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 1 | 4 | |
| other | Nausea | Gastrointestinal disorders | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | 3 | 8 | |
| other | Nausea | Gastrointestinal disorders | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | 1 | 2 | |
| other | Nausea | Gastrointestinal disorders | All Patients | 7 | 17 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 1 | 4 |
| Total, all-cause mortality | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 1 | 3 |
| Total, all-cause mortality | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | 5 | 8 |
| Total, all-cause mortality | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | 1 | 2 |
| Total, all-cause mortality | All Patients | 8 | 17 |
| Total, other adverse events | Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV | 4 | 4 |
| Total, other adverse events | Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV | 3 | 3 |
| Total, other adverse events | Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV | 8 | 8 |
| Total, other adverse events | Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV | 2 | 2 |
| Total, other adverse events | All Patients | 17 | 17 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
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/NCT02154529
GET https://conductscience.org/api/trials/v1/NCT02154529/results?page=2