Drugs / Volasertib
Volasertib
also known as
BI6727 · BI 6727 CL3 · BI 6727 TRIHYDROCHLORIDE · Volasertib hydrochloride · VOLASERTIB TRIHYDROCHLORIDE
Small molecule targets PLK1 via inhibition
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 120 trials | ||||||
| Phase 1 | NCT02722135 | Nov 2016 → May 2018 | acute myeloid leukemia | Boehringer Ingelheim | Withdrawn | No outcome recorded |
| Phase 1 | NCT02527174 | Nov 2016 → May 2018 | acute erythroid leukemia, acute megakaryoblastic leukemia, acute monocytic leukemia, acute myelomonocytic leukemia M4 | University of Alberta | Withdrawn | No outcome recorded |
| Phase 1 | NCT02757248 | Nov 2016 | primary cutaneous T-cell lymphoma | Anne Beaven, MD | Withdrawn | No outcome recorded |
| Phase 1 | NCT02875002 | Oct 2016 → Mar 2018 | lymphoma | Yale University | Withdrawn | No outcome recorded |
| Phase 1 | NCT02905994 | Sep 2016 → Feb 2017 | acute myeloid leukemia | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02861040 | Aug 2016 → Jul 2018 | adult acute lymphoblastic leukemia | Northwestern University | Withdrawn | No outcome recorded |
| Phase 1 | NCT02721875 | Apr → Jun 2016 | myelodysplastic syndrome | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02201329 | Aug 2014 → Jan 2015 | chronic myelomonocytic leukemia, myelodysplastic syndrome | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02003573 | Jan 2014 → Jan 2015 | acute myeloid leukemia | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01957644 | Nov 2013 → Dec 2016 | chronic myelomonocytic leukemia, myelodysplastic syndrome | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01971476 | Oct 2013 → Jun 2015 | leukemia | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01772563 | Feb 2013 → May 2014 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01662505 | Aug 2012 → May 2015 | acute myeloid leukemia | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01348347 | Apr 2011 → Aug 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01206816 | Oct 2010 → Nov 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01145885 | Jun → Nov 2010 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01022853 | Dec 2009 → Feb 2013 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00969553 | Aug 2009 → Sep 2011 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00969761 | Aug 2009 → Nov 2011 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02273388 | Nov 2005 → Jan 2009 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 25 trials · 3 missed | ||||||
| Phase 2 | NCT02198482 | Feb → Nov 2016 | acute myeloid leukemia, myelodysplastic syndrome | University of Ulm | Terminated | No outcome recorded |
| Phase 2 | NCT01121406 | Apr 2010 → Jun 2014 | ovarian neoplasm | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT01023958 | Nov 2009 → Sep 2011 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00824408 | Mar 2009 → Sep 2012 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00804856 | Nov 2008 → Mar 2012 | acute myeloid leukemia | Boehringer Ingelheim | Completed | Missed primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01721876 | Jan 2013 → Aug 2014 | acute myeloid leukemia | Boehringer Ingelheim | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2014-07-08 | Boehringer Ingelheim | Results Boehringer Ingelheim's volasertib Phase II data including new overall survival results in older patients with acute myeloid leukemia published in Blood prnewswire.com ↗
The trial showed patients treated with volasertib combined with LDAC had a median overall survival of 8 months versus 5.2 months in patients treated with LDAC (p=0.047). |
| 2014-04-17 | Boehringer Ingelheim | Regulatory Volasertib, Boehringer Ingelheim's Investigational Oncology Compound, is Granted Orphan Drug Designation for Acute Myeloid Leukemia in the U.S. and EU prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). |
| 2013-09-17 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim's investigational volasertib receives FDA Breakthrough Therapy designation prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced the FDA has granted Breakthrough Therapy designation to volasertib* |
| 2012-12-10 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents New Phase II Data for Volasertib in Adult Patients with AML prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today reported preliminary results from the randomized Phase II part of a Phase I/II study involving the company's investigational compound volasertib in newly diagnosed patients with acute myeloid leukemia (AML) considered ineligible for intensive remission induction therapy. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-07-08 | Boehringer Ingelheim | Boehringer Ingelheim's volasertib Phase II data including new overall survival results in older patients with acute myeloid leukemia published in Blood prnewswire.com ↗ |
| 2014-04-17 | Boehringer Ingelheim | Volasertib, Boehringer Ingelheim's Investigational Oncology Compound, is Granted Orphan Drug Designation for Acute Myeloid Leukemia in the U.S. and EU prnewswire.com ↗ |
| 2013-09-17 | Boehringer Ingelheim | Boehringer Ingelheim's investigational volasertib receives FDA Breakthrough Therapy designation prnewswire.com ↗ |
| 2012-12-10 | Boehringer Ingelheim | Boehringer Ingelheim Presents New Phase II Data for Volasertib in Adult Patients with AML prnewswire.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Volasertib | “Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC” NCT00824408 ↗21“Volasertib (BI 6727), a Plk inhibitor, has demonstrated antitumor activity in several malignancies, including UC.” PMID 24339028 ↗ Dec 2013 “Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers” NCT00969553 ↗ “A phase I study of volasertib combined with afatinib, in advanced solid tumors.” PMID 26349473 ↗ Sep 2015 “BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours” NCT01145885 ↗ |
| Known as | BI 6727 CL3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1233528 ↗ |
| Known as | BI 6727 TRIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1233528 ↗ |
| Known as | BI6727 | “An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours” NCT01206816 ↗9“Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC” NCT00824408 ↗ “Volasertib (BI 6727), a Plk inhibitor, has demonstrated antitumor activity in several malignancies, including UC.” PMID 24339028 ↗ Dec 2013 “Volasertib (BI6727) is a small molecule inhibitor of the polo-like kinase 1 (PLK1) protein.” NCT02875002 ↗ |
| Known as | Volasertib hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1233528 ↗ |
| Known as | VOLASERTIB TRIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1233528 ↗ |
| Action | Inhibit | “a selective Polo-like kinase 1 inhibitor” PMID 25794535 ↗ Mar 2015 |
| Modality | Small molecule | “Volasertib (BI6727) is a small molecule inhibitor of the polo-like kinase 1 (PLK1) protein.” NCT02875002 ↗ |
| Route | Intravenous | “Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).” NCT00804856 ↗ |
| Target | PLK1 | “Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory...” NCT01121406 ↗ |