Trial Outcomes & Findings for Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers (NCT NCT01848756)
NCT ID: NCT01848756
Last Updated: 2017-02-09
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 24 months from last patient entry
Results posted on
2017-02-09
Participant Flow
Participant milestones
| Measure |
SNX-5422
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
SNX-5422
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Enrolled in Error
|
1
|
Baseline Characteristics
Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers
Baseline characteristics by cohort
| Measure |
SNX-5422
n=15 Participants
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
|
Gender
Female
|
9 Participants
n=99 Participants
|
|
Gender
Male
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 24 months from last patient entryPopulation: 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
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Every 3 months until 24 months after the last subject has been enrolledPopulation: 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
Time on treatment with at worst stable disease.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Every 3 months until 24 months after the last subject has been enrolledPopulation: 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
Time from start of treatment that patients remain alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 28 of each cyclePopulation: All Treated Subjects
Number of patients experiencing treatment emergent adverse events.
Outcome measures
| Measure |
SNX-5422
n=15 Participants
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Number of Patients With Adverse Events
|
15 participants
|
SECONDARY outcome
Timeframe: Day 28 of each cyclePopulation: All Treated Subjects
Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received.
Outcome measures
| Measure |
SNX-5422
n=15 Participants
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
All laboratory abnormalities
|
8 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
ALT/AST increases
|
6 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
Alkaline phosphatase increase
|
3 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
Vital signs
|
0 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
Systolic/diastolic blood pressure
|
0 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
Respiratory rate
|
0 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
Temperature
|
0 participants
|
|
Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline
ECG
|
0 participants
|
SECONDARY outcome
Timeframe: Screening, end of Cycle 1, final visitPopulation: ll Treated Subjects
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
Outcome measures
| Measure |
SNX-5422
n=15 Participants
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Ophthalmologic Changes From Baseline
|
1 participants
|
SECONDARY outcome
Timeframe: Every 28 day cyclePopulation: All treated subjects
Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament
Outcome measures
| Measure |
SNX-5422
n=15 Participants
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Adverse Events by Severity and Relationship to Treatment
Subjects with adverse events
|
15 participants
|
|
Adverse Events by Severity and Relationship to Treatment
Subjects with Grade 3 or 4 adverse events
|
8 participants
|
|
Adverse Events by Severity and Relationship to Treatment
Subjects with Grade 5 adverse events
|
2 participants
|
|
Adverse Events by Severity and Relationship to Treatment
Subjects with treatment related adverse events
|
15 participants
|
|
Adverse Events by Severity and Relationship to Treatment
Subjects with Grade 3 or 4 AEs related to treatmen
|
7 participants
|
|
Adverse Events by Severity and Relationship to Treatment
Subjects with Grade 5 AEs related to treatment
|
0 participants
|
Adverse Events
SNX-5422
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SNX-5422
n=15 participants at risk
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Renal and urinary disorders
Renal Failure Acute
|
13.3%
2/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Haematemesis
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Cardiac disorders
Cardiac Tamponade
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Cardiac disorders
Pericardial Effusion
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Infections and infestations
Wound Infection
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
General disorders
Asthenia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Hepatobiliary disorders
Jaundice
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
Other adverse events
| Measure |
SNX-5422
n=15 participants at risk
Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.
SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
86.7%
13/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
8/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
3/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Dry Mouth
|
13.3%
2/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
20.0%
3/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
2/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
2/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Metabolism and nutrition disorders
hyponatraemia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
General disorders
Fatigue
|
40.0%
6/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
General disorders
Chills
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
General disorders
Mucosal Inflammation
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Aspartate Aminotransferase increased
|
33.3%
5/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Alanine Aminotransferase Increased
|
20.0%
3/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
13.3%
2/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Blood Cholesterol Increased
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Blood Creatinine Increased
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
Lymphocyte Count Decreased
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Investigations
White Blood Cell Count Decreased
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
4/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Eye disorders
Vision Blurred
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Renal and urinary disorders
Renal Failure Acute
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
6.7%
1/15 • From patient screening to removal from study, average time on study 49+/-16 days
Regular Investigator Assessment including patient volunteered reports
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60