Trial · NCT01848756
Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers
NCT01848756, Phase 1, Phase 2, Terminated, Esanex Inc.; results first posted 2016-11-21
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers. Trials, record NCT01848756. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01848756
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers
- NCT number
- NCT01848756
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Esanex Inc.
- Conditions
- Cancer
- Interventions
- SNX-5422
- First posted
- 2013-05-07
- Last updated
- 2017-02-09
- Results first posted
- 2016-11-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Up to 24 months from last patient entry | The effect of SNX-5422 on tumor progression. Objective tumor responses (complete remissions plus partial remissions) and clinical benefit rate (complete remissions plus partial remissions plus stable disease at 6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST). |
| Primary | Progression Free Survival | Every 3 months until 24 months after the last subject has been enrolled | Time on treatment with at worst stable disease. |
| Primary | Overall Survival | Every 3 months until 24 months after the last subject has been enrolled | Time from start of treatment that patients remain alive. |
| Secondary | Number of Patients With Adverse Events | Day 28 of each cycle | Number of patients experiencing treatment emergent adverse events. |
| Secondary | Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | Day 28 of each cycle | Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received. |
| Secondary | Ophthalmologic Changes From Baseline | Screening, end of Cycle 1, final visit | Ophthalmologic assessments will be presented by cohort, study visit and dose. Number of subjects experiencing clinically relevant changes from baseline in any of these examinations will be presented using descriptive summary |
| Secondary | Adverse Events by Severity and Relationship to Treatment | Every 28 day cycle | Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament |
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 | Objective Response Rate | Up to 24 months from last patient entry | Per protocol population including all enrolled evaluable subjects.Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 6 months on study, the first analysis time point for this endpoint, at the time of study termination | ||
| PRIMARY | Progression Free Survival | Every 3 months until 24 months after the last subject has been enrolled | Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination | ||
| PRIMARY | Overall Survival | Every 3 months until 24 months after the last subject has been enrolled | Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination | ||
| SECONDARY | Number of Patients With Adverse Events | Day 28 of each cycle | All Treated Subjects | participants | NUMBER |
| SECONDARY | Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | Day 28 of each cycle | All Treated Subjects | participants | NUMBER |
| SECONDARY | Ophthalmologic Changes From Baseline | Screening, end of Cycle 1, final visit | ll Treated Subjects | participants | NUMBER |
| SECONDARY | Adverse Events by Severity and Relationship to Treatment | Every 28 day cycle | All treated subjects | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events | SNX-5422 | 15 | participants | ||
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | All laboratory abnormalities | 8 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | ALT/AST increases | 6 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | Alkaline phosphatase increase | 3 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | Vital signs | 0 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | Systolic/diastolic blood pressure | 0 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | Respiratory rate | 0 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | Temperature | 0 | participants | |
| Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline | SNX-5422 | ECG | 0 | participants | |
| Ophthalmologic Changes From Baseline | SNX-5422 | 1 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SNX-5422 | 15 | |
| Overall Study | COMPLETED | SNX-5422 | 12 | |
| Overall Study | NOT COMPLETED | SNX-5422 | 3 |
Source ClinicalTrials.gov
Adverse events49
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 | Diarrhoea | Gastrointestinal disorders | SNX-5422 | 13 | 15 | |
| other | Nausea | Gastrointestinal disorders | SNX-5422 | 8 | 15 | |
| other | Vomiting | Gastrointestinal disorders | SNX-5422 | 8 | 15 | |
| other | Abdominal Pain | Gastrointestinal disorders | SNX-5422 | 3 | 15 | |
| other | Constipation | Gastrointestinal disorders | SNX-5422 | 2 | 15 | |
| other | Dry Mouth | Gastrointestinal disorders | SNX-5422 | 2 | 15 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | SNX-5422 | 1 | 15 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | SNX-5422 | 3 | 15 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | SNX-5422 | 2 | 15 | |
| other | Hypoalbuminaemia | Metabolism and nutrition disorders | SNX-5422 | 2 | 15 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SNX-5422 | ||
| Total, other adverse events | SNX-5422 | 15 | 15 |
| Total, serious adverse events | SNX-5422 | 8 | 15 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01848756
GET https://conductscience.org/api/trials/v1/NCT01848756/events?page=2