Drugs / enzastaurin
enzastaurin
also known as
LY317615 · Enzastaurin Hydrochloride · DB-102 · Enzastaurin HCL · Enzastaurin monohydrochloride · Enzastaurina · Enzastaurine · Kinenza · +1 more
Small molecule targets PRKCB via inhibition
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT01432951 | Nov 2011 → Jan 2013 | cancer, lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01388335 | Aug 2011 → Oct 2012 | cancer, lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00516607 | Jul 2007 → Nov 2008 | central nervous system neoplasm | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 1 | NCT00503724 | Jun 2007 → May 2010 | central nervous system neoplasm, neuroblastoma | Pediatric Brain Tumor Consortium | Completed | No outcome recorded |
| Phase 1 | NCT00452257 | May 2007 → Sep 2008 | lymphoid leukemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01445119 | Jan 2007 → Jul 2013 | malignant glioma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00550927 | Nov 2006 → Mar 2010 | cancer of unknown primary site | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00108056 | Apr 2005 → Apr 2014 | glioma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00052273 | Dec 2002 → Nov 2004 | cancer | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00452413 | May 2007 → Jul 2009 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT00402116 | Sep 2006 → Dec 2009 | gliosarcoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 234 trials · 10 missed | ||||||
| Phase 2 | NCT00744991 | Sep 2008 → Jan 2010 | primary cutaneous T-cell lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00718419 | Jul 2008 → Sep 2010 | Waldenstrom macroglobulinemia, plasma cell myeloma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00709995 | Jun 2008 → Feb 2010 | renal cell carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00612586 | Feb 2008 → Jan 2010 | colorectal cancer | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00414960 | Dec 2007 → Sep 2010 | lung cancer | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00542919 | Nov 2007 → Mar 2010 | B-cell non-Hodgkin lymphoma, T-cell non-Hodgkin lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00586508 | Nov 2007 → Oct 2013 | glioblastoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00536939 | Nov 2007 → Mar 2008 | breast cancer | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00533429 | Oct 2007 → Feb 2009 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00509821 | Oct 2007 → Feb 2010 | glioblastoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00530621 | Sep 2007 → Oct 2008 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00538681 | Sep 2007 → Nov 2008 | lung cancer | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2 | NCT00466440 | Jun 2007 → Aug 2009 | prostate cancer | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00469976 | Jun 2007 → ? | lung cancer | Eastern Cooperative Oncology Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT00475644 | May 2007 → Apr 2012 | follicular lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00451178 | May 2007 → Feb 2012 | lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00451555 | Apr 2007 → Dec 2010 | breast cancer | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00437268 | Mar 2007 → May 2009 | colorectal carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00437294 | Mar 2007 → Mar 2009 | breast cancer | Eli Lilly and Company | Terminated | Missed primary |
| Phase 2 | NCT00436280 | Feb 2007 → Nov 2009 | diffuse large B-cell lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00420381 | Jan 2007 → May 2008 | carcinoma, ovarian cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00428714 | Jan 2007 → Jun 2009 | prostate cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00415363 | Dec 2006 → Jan 2011 | non-small cell lung carcinoma, small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00386087 | Nov 2006 → Sep 2007 | breast cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00391118 | Nov 2006 → Apr 2010 | fallopian tube neoplasm, ovarian cancer, peritoneal neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00407758 | Nov 2006 → Aug 2016 | ovarian carcinoma, peritoneal carcinoma | Gynecologic Oncology Group | Completed | Missed primary |
| Phase 2 | NCT00309140 | Mar 2006 → Jul 2009 | cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00308750 | Mar 2006 → Jul 2009 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00267020 | Dec 2005 → May 2008 | pancreatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00192114 | Aug 2005 → Mar 2008 | colonic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00105092 | Mar 2005 → Feb 2007 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00088205 | Mar 2004 → May 2008 | mantle cell lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00190723 | Oct 2002 → Dec 2006 | malignant glioma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00042666 | Jun 2002 → Sep 2008 | non-Hodgkin lymphoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT00332202 | Jun 2006 → Apr 2013 | non-Hodgkin lymphoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00295815 | Jan 2006 → Aug 2007 | glioblastoma | Eli Lilly and Company | Completed | Missed primary |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT00685633 Comparator | Dec 2008 → Jun 2010 | prostate cancer | Eastern Cooperative Oncology Group | Withdrawn | No outcome recorded |
| Phase 3 | NCT05463679 Comparator | Jan → Jun 2025 | Ehlers-Danlos syndrome, vascular type | Aytu BioPharma, Inc. | Suspended | No outcome recorded |
| Phase 3 | NCT03776071 Comparator | Dec 2020 → Feb 2024 | glioblastoma | Denovo Biopharma LLC | Completed | No outcome recorded |
| Phase 3 | NCT03263026 Comparator | Mar 2018 → Aug 2022 | diffuse large B-cell lymphoma | Denovo Biopharma LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2019-05-17 | Denovo Biopharma LLC | Results Three DB102 (Enzastaurin) Presentations at ASCO and the 15th International Conference on Malignant Lymphoma (ICML) denovobiopharma.com ↗
In both studies, DGM1+ patients had significantly increased overall survival (OS) compared to DGM1- patients. |
| 2013-05-10 | Eli Lilly and Company | Results Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large B-Cell Lymphoma lilly.com ↗
The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. |
| 2007-06-02 | Eli Lilly and Company | Results Targeted, Oral Agent Enzastaurin Shows Favorable Results in Late-Stage Lung Cancer lilly.com ↗
In the 54 patients enrolled, the median progression-free survival was 1.9 months (95% Confidence Interval: 1.7-1.9) and the progression-free survival rate at six months was 14% (95% CI: 4.4%-23.6%). |
| 2007-03-26 | Eli Lilly and Company | Regulatory Enzastaurin Granted Orphan Drug Status for Treatment of Diffuse Large B-Cell Lymphoma (DLBCL) lilly.com ↗
Eli Lilly and Company announced today that the European Medicines Agency (EMEA) has granted enzastaurin, an investigational, multi-targeted, oral, cancer agent, orphan drug designation for the treatment of diffuse large B-cell lymphoma (DLBCL). |
| 2006-12-21 | Eli Lilly and Company | Results Data Monitoring Committee Recommends Closing Enrollment in Recurrent Glioblastoma Study lilly.com ↗
Results of this planned interim analysis suggested that enzastaurin would not meet the primary endpoint of improvement in progression-free survival over an existing chemotherapy in this particular study. |
| 2006-06-04 | Eli Lilly and Company | Results New Data Show Enzastaurin's Activity Across Multiple Cancer Cell Lines lilly.com ↗
Clinical results also highlighted enzastaurin's potential to enhance the benefit of standard-of-care chemotherapies such as GEMZAR(R) (gemcitabine HCl), ALIMTA(R) (pemetrexed) and Xeloda(R) (capecitabine) with manageable side effects. |
| 2005-12-10 | Eli Lilly and Company | Results Investigational Targeted Therapy May Offer Progress for Non-Hodgkin's Lymphoma Patients lilly.com ↗
Phase II data presented today at the American Society of Hematology (ASH) 47th Annual Meeting and Exposition in Atlanta, Georgia, showed enzastaurin HCl, an investigational compound from Lilly Oncology, slowed the progression of DLBCL in several patients pretreated with chemotherapy. |
| 2005-05-17 | Eli Lilly and Company | Results Lilly Targeted Agent Shows Promise in Treating Primary Brain Cancer lilly.com ↗
Preliminary results from a Phase II clinical trial show patients with recurrent glioblastoma multiforme, a form of primary brain cancer, experienced a significant tumor response rate with minimal side effects when treated with enzastaurin |
All press releases naming this drug 9 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | enzastaurin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00451178 ↗ |
| Known as | DB-102 | ChEMBL registry synonym — accepted as the source's own label CHEMBL300138 ↗ |
| Known as | Enzastaurin HCL | “Phase IIB Randomized, Placebo-Controlled, Double-Blind Study of Enzastaurin HCL (LY317615) for Lung Cancer Prevention in Former Smokers” NCT00414960 ↗ |
| Known as | Enzastaurin Hydrochloride | “Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1.” NCT00407758 ↗2“Patients receive oral enzastaurin hydrochloride once or twice daily on days 1-28” NCT00516607 ↗ “Drug: Enzastaurin Hydrochloride” NCT03263026 ↗ |
| Known as | Enzastaurin monohydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL300138 ↗ |
| Known as | Enzastaurina | ChEMBL registry synonym — accepted as the source's own label CHEMBL300138 ↗ |
| Known as | Enzastaurine | ChEMBL registry synonym — accepted as the source's own label CHEMBL300138 ↗ |
| Known as | Kinenza | ChEMBL registry synonym — accepted as the source's own label CHEMBL300138 ↗ |
| Known as | LY-317615 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL300138 ↗ |
| Known as | LY317615 | “A phase I study of LY317615 (enzastaurin) and temozolomide in patients with gliomas” PMID 22291006 ↗ Jan 20124“Enzastaurin (LY317615) monohydronchloride” NCT00108056 ↗ “Enzastaurin (LY317615)” NCT01445119 ↗ “enzastaurin (LY317615)” NCT01388335 ↗ |
| Action | Inhibit | “blocking the enzymes necessary for cancer cell growth” NCT00052273 ↗1“Protein kinase C beta inhibitor” CHEMBL300138 ↗ |
| Modality | Small molecule | “Enzastaurin is a macrocyclic bisindolylmaleimide” NCT00108056 ↗ |
| Route | Oral | “500 mg, oral, QD, up to six 28 day cycles” NCT00042666 ↗ |
| Target | PRKCB | “Protein kinase C beta inhibitor” CHEMBL300138 ↗ |