AFFINITY Trial
To evaluate a survival benefit for custirsen in combination with second-line cabazitaxel treatment in approximately 630 men with CRPC
Custirsen (OGX-011)
About Custirsen
Custirsen is an experimental drug that is designed to block the production of clusterin, a cell-survival protein that is over-produced in several malignancies and in response to many cancer treatments. Clusterin expression can be associated with treatment resistance and has been linked to faster rates of cancer progression and shorter survival duration.
Clinical Trial Results
- Custirsen has been administered to nearly 300 patients with various types of cancer in Phase 1 and Phase 2 clinical trials.
- A broad range of preclinical studies show that custirsen decreases clusterin levels and sensitizes tumor cells to standard chemotherapeutic drugs.
- Custirsen’s ability to enhance the effects of standard therapies has been evaluated in five Phase 2 clinical trials. The Phase 2 results in prostate cancer suggest there may be an overall survival benefit as well as an improvement in durable pain palliation in prostate cancer. Phase 2 results in lung cancer suggest survival outcomes compared favorably with previously published data of similar regimens.
Learn more about Phase 1 Clinical Trial Results.
Learn more about Phase 2 Clinical Trial Results.
ENSPIRIT Trial
To evaluate a survival benefit for custirsen in combination with second-line docetaxel treatment in approximately 1,100 patients with NSCLC.
SYNERGY Trial
To evaluate a survival benefit for custirsen in combination with first-line docetaxel treatment in approximately 1000 patients with CRPC
Clinical Development Program
AFFINITY: Phase 3 Study of Custirsen in Second-Line CRPC
Study Design: Randomized, open-label, two-arm study of Custirsen in ~630 CRPC patients who have documented disease progression after prior first-line docetaxel treatment.
Arm B: Cabazitaxel + Prednisone
Primary Endpoint: Overall survival
Estimated Accrual Completion: December 2015
ENSPIRIT: Phase 3 Study of Custirsen in advanced NSCLC
Study Design: Randomized, open-label, two-arm study of Custirsen in ~1,100 patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after initial chemotherapy treatment has failed.
Arm B: Docetaxel
Primary Endpoint: Overall survival
Estimated Primary Endpoint Date: 2017
SYNERGY: Phase 3 Study of Custirsen in Chemotherapy - Naive CRPC
Study Design: Randomized, open-label, two-arm study of Custirsen in ~1000 chemotherapy-naive CRPC patients.
Arm B: Docetaxel + Prednisone
Primary Endpoint: Overall survival
Estimated Accrual Completion: Q4:2012
Estimated Primary Endpoint Date: YE 2013
- SPA completed with the FDA
- Received Fast Track Designation
- FDA stated that an application supported primarily by the results of SYNGERGY alone would be acceptable for submission.
This section is intended specifically for healthcare professionals. Information is provided for educational use only, based on pre-clinical and clinical data of custirsen. Custirsen is not approved for commercial use and is only available for investigational use in approved clinical trials.
