Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
|ClinicalTrials.gov Identifier: NCT02215850|
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : May 17, 2016
SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in development for the treatment of solid tumours over-expressing CA IX. CAIX, a transmembrane metalloenzyme, is overexpressed on extracellular surfaces of hypoxic tumour cells but its expression is highly restricted in normal tissue. CAIX is a functional regulator of processes critical for tumour growth and metastasis, including pH regulation, survival, migration and invasion.
This prospective single arm study will evaluate the safety of SLC-0111 given once daily in 28 day cycles in subjects with advanced solid tumours. The intent of this research study is to find our more information such as: the highest dose of SLC-0111 that can be given safely, the side effect it may cause, to examine how the body affects the study drug concentration in the blood (pharmacokinetics or PK), and to gain some information on its effectiveness in treating cancer.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumours||Drug: SLC-0111||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Multi-center, Open-label, Study to Investigate the Safety, Tolerability and Pharmacokinetic of SLC-0111 in Subjects With Advanced Solid Tumours|
|Study Start Date :||October 2014|
|Primary Completion Date :||March 2016|
|Study Completion Date :||March 2016|
|Experimental: SLC-0111||Drug: SLC-0111|
- Number of participants with adverse events [ Time Frame: 1 year. Subjects will continue to receive SLC-0111 for multiple cycles of 28 days if they are receiving benefit from therapy. ]To evaluate the safety and tolerability of SLC-0111, administered once daily, in subjects with advanced solid tumours.
- Area under the plasma concentration versus time curve (AUC) of SLC-0111 [ Time Frame: 1 year. ]Changes in AUC over time in subjects taking SLC-0111 once daily.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215850
|Alberta Health Services - Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|