Drugs / custirsen
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01874561 | May → Dec 2013 | cardiac conduction defect | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01497470 | Apr 2012 → Jul 2013 | cancer | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT00471432 | Apr 2003 → Mar 2006 | breast cancer, cancer of unknown primary site, kidney cancer, lung cancer +3 | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 1 | NCT00054106 | Dec 2002 → Sep 2004 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00138658 | Nov 2004 → Mar 2010 | non-small cell lung carcinoma | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT00327340 | Jul 2006 → Oct 2010 | prostate cancer | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00258375 | Oct 2005 → Feb 2007 | breast cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 2 | NCT00138918 | Jun 2005 → May 2008 | prostate cancer | University of British Columbia | Completed | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT01630733 | Oct 2012 → Nov 2016 | non-small cell lung carcinoma | Achieve Life Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01578655 | Aug 2012 → Jul 2016 | prostate cancer | Achieve Life Sciences | Completed | Missed primary |
| Phase 3 | NCT01188187 | Nov 2010 → Feb 2014 | prostate cancer | Achieve Life Sciences | Completed | Missed primary |
| Phase 3 | NCT01083615 | Mar 2010 → Mar 2013 | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma | Achieve Life Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00258388 Comparator | Sep 2005 → Nov 2007 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2014-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and OncoGenex Announce Top-Line Survival Results of Phase III SYNERGY Trial Evaluating Custirsen in Combination with First-line Docetaxel and Prednisone for Metastatic Castrate-Resistant Prostate Cancer tevapharm.com ↗
The adverse events (AEs) observed for custirsen were similar to its known AE profile. |
| 2011-05-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and OncoGenex to Present Data on Custirsen in Prostate Cancer at the 2011 ASCO Annual Meeting tevapharm.com ↗
Findings from the two pre-clinical studies that will be presented demonstrate the clinical potential of custirsen combinability with anti-cancer agents in the treatment of prostate cancer. |
| 2011-04-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and OncoGenex Present Preclinical Data on the Activity of its Antisense Compound Custirsen (OGX-011/TV-1011) at the American Association of Cancer Research (AACR) Annual Meeting 2011 tevapharm.com ↗
Study results show that clusterin regulates epithelial-mesenchymal transition (EMT) induced by the growth factor TGF beta and the transcription factor TWIST1 in prostate cancer cells. |
| 2009-06-01 | Ionis Pharmaceuticals | Results Isis Highlights New Clinical Data on Anti-Cancer Antisense Drugs Featured at ASCO ionis.com ↗
results from a Phase 2 study of OGX-011 in patients with advanced metastatic prostate cancer |
| 2008-12-03 | Ionis Pharmaceuticals | Results Isis Announces That OGX-011 Has Shown Overall Survival Advantage in Prostate Cancer Compared to Standard Therapy in a Randomized Phase 2 Study ionis.com ↗
The current 10.6 month median overall survival advantage observed in the OGX-011 arm represents an increase over the median survival observed in the control arm. |
| 2008-06-02 | Ionis Pharmaceuticals | Results Isis' Partners Present Clinical Data on Antisense Drugs at the American Society of Clinical Oncology ionis.com ↗
Encouraging data from this trial support initiation of registration trials required for product approval. |
| 2007-07-31 | Ionis Pharmaceuticals | Results OncoGenex and Isis Report Encouraging Interim Phase II Data in Advanced Prostate Cancer, Affirm Phase III Clinical Trial Plans ionis.com ↗
Patients receiving the combination of OGX-011 and re-treatment with docetaxel in the second-line setting are achieving longer survival, longer progression-free survival and more frequent prostate-specific antigen (PSA) decreases than patients treated with OGX-011 in combination with mitoxantrone, a standard second-line chemotherapeutic agent. |
| 2007-06-03 | Ionis Pharmaceuticals | Results Study Presented at ASCO Shows Encouraging One-Year and Overall Survival Results for Phase I/II Trial of OGX-011 in Non-Small Cell Lung Cancer ionis.com ↗
At the time of analysis, the estimated median overall survival was 14 months, with follow up ongoing. |
| 2007-06-02 | Ionis Pharmaceuticals | Results Study Presented at ASCO Shows Encouraging Preliminary Results for Phase II Trial of OGX-011 in Advanced Prostate Cancer ionis.com ↗
OncoGenex Technologies Inc. and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today announced preliminary data from a Phase II clinical trial of OGX-011 in combination with docetaxel and prednisone in patients with metastatic hormone refractory prostate cancer (HRPC). |
| 2004-06-06 | Ionis Pharmaceuticals | Results OncoGenex and Isis Pharmaceuticals Announce Compelling Data from Phase I Prostate Cancer Study at ASCO Annual Meeting ionis.com ↗
The Phase I study demonstrates, for the first time, the ability of OGX-011 to potently inhibit clusterin expression in primary prostate cancers. |
All press releases naming this drug 16 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | custirsen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00138658 ↗ |
| Known as | custirsen sodium | “Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose).” NCT00138658 ↗1“Drug: custirsen sodium” NCT00258388 ↗ |
| Known as | OGX-011 | “OGX-011 is a 2'-methoxyethyl modified phosphorothioate antisense oligonucleotide that is complementary to clusterin mRNA and has been reported to inhibit clusterin expression...” PMID 16145049 ↗ Sep 20053“Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose).” NCT00138658 ↗ “Custirsen (OGX-011) on the Pharmacokinetics of Paclitaxel” NCT01497470 ↗ |
| Action | Inhibit | “an inhibitor of CLU protein production” PMID 22198426 ↗ Mar 2012 |
| Modality | Antisense oligonucleotide | “Custirsen, a second-generation antisense oligonucleotide, inhibits CLU production in tumor cells and reduces serum CLU levels.” PMID 24156019 ↗ May 2013 |
| Route | Intravenous | “OGX-011 by 2-hour intravenous infusion” PMID 16145049 ↗ Sep 2005 |
| Target | CLU | “an inhibitor of CLU protein production” PMID 22198426 ↗ Mar 2012 |