Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers
|ClinicalTrials.gov Identifier: NCT01848756|
Recruitment Status : Terminated (Business reasons)
First Posted : May 7, 2013
Results First Posted : November 21, 2016
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: SNX-5422||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Phase 1/2 Study of SNX-5422 in Subjects With Selected HER2 Positive Cancers.|
|Study Start Date :||April 2013|
|Primary Completion Date :||February 2015|
|Study Completion Date :||June 2015|
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.
Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
- Objective Response Rate [ Time Frame: 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).
- Progression Free Survival [ Time Frame: Every 3 months until 24 months after the last subject has been enrolled ]Time on treatment with at worst stable disease.
- Overall Survival [ Time Frame: Every 3 months until 24 months after the last subject has been enrolled ]Time from start of treatment that patients remain alive.
- Number of Patients With Adverse Events [ Time Frame: Day 28 of each cycle ]Number of patients experiencing treatment emergent adverse events.
- Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline [ Time Frame: Day 28 of each cycle ]Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received.
- Ophthalmologic Changes From Baseline [ Time Frame: 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
- Adverse Events by Severity and Relationship to Treatment [ Time Frame: Every 28 day cycle ]Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848756
|United States, Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|