MedPath

Custirsen

Generic Name
Custirsen
Drug Type
Biotech
CAS Number
890056-27-6
Unique Ingredient Identifier
L26E95NLRK
Background

Custirsen is a benzopyran with potential antineoplastic activity. Custirsen acts as a selective estrogen receptor modulator (SERM), inhibiting the proliferation of estrogen-sensitive breast cancer cells. This agent also inhibits growth and induces apoptosis of glioblastoma cells via a mechanism independent of estrogen receptor-related mechanisms. Custirsen is also being investigated in the treatment of primary brain tumors.

Indication

Investigated for use/treatment in brain cancer and breast cancer.

Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization

Phase 1
Completed
Conditions
Cardiac Conduction and Repolarization
Interventions
First Posted Date
2013-06-11
Last Posted Date
2016-10-10
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
155
Registration Number
NCT01874561
Locations
🇺🇸

Teva Investigational Site 10565, Lenexa, Kansas, United States

A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

Phase 3
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2012-06-28
Last Posted Date
2016-07-01
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
700
Registration Number
NCT01630733
Locations
🇪🇸

Hospital Universitario La Paz, Madrid, Spain

🇺🇸

University Cancer Institute, Soynton Beach, Florida, United States

🇪🇸

Hospital Universitario Doctor Peset, Valencia, Spain

and more 78 locations

Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2012-04-17
Last Posted Date
2016-10-12
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
630
Registration Number
NCT01578655
Locations
🇺🇸

Georgia Cancer Specialists, P.C., Marietta, Georgia, United States

🇨🇦

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

🇨🇿

Krajská nemocnice Liberec a.s., Liberec, Czech Republic

and more 90 locations

Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-08-25
Last Posted Date
2016-10-14
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
1022
Registration Number
NCT01188187
Locations
🇳🇱

Teva Investigational Site 852, Rotterdam, Netherlands

🇺🇸

Teva Investigational Site 093, Marina del Rey, California, United States

🇺🇸

Teva Investigational Site 100, Birmingham, Alabama, United States

and more 137 locations

A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Phase 3
Terminated
Conditions
Hormone Refractory Prostate Cancer
Castrate-Resistant Prostate Cancer
Interventions
First Posted Date
2010-03-10
Last Posted Date
2016-10-12
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
14
Registration Number
NCT01083615

OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors

Phase 1
Completed
Conditions
Breast Cancer
Kidney Cancer
Bladder Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Lung Cancer
Prostate Cancer
First Posted Date
2007-05-10
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
40
Registration Number
NCT00471432

Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2006-05-18
Last Posted Date
2012-10-05
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
70
Registration Number
NCT00327340
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

🇨🇦

Tom Baker Cancer Centre, Calgary, Alberta, Canada

🇨🇦

BC Cancer Agency, Vancouver, British Columbia, Canada

and more 7 locations

Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-11-24
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
82
Registration Number
NCT00258388
Locations
🇨🇦

London Regional Cancer Program, London, Canada

🇨🇦

BCCA - Cancer Centre for the Southern Interior, Kelowna, Canada

🇺🇸

University of Washington, Seattle, Washington, United States

and more 10 locations

OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
First Posted Date
2005-11-24
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
15
Registration Number
NCT00258375
Locations
🇨🇦

British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada

🇨🇦

British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada

and more 2 locations

A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Completed
Conditions
Non-small Cell Lung Cancer
First Posted Date
2005-08-30
Last Posted Date
2012-02-06
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
85
Registration Number
NCT00138658
Locations
🇨🇦

Toronto Sunnybrook Regional Cancer Center, Toronto, Ontario, Canada

🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

🇺🇸

Cancer Centers of the Carolinas, Greenville, South Carolina, United States

and more 12 locations
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