16 completed, 6 withdrawn, 3 terminated. 19 Phase 1, 5 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 19 | Completed 11, Withdrawn 6, Terminated 2 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 1 | Completed 1 |
Follow BI 6727: new trials by email Literature Review of BI 6727 trials Research Report on BI 6727
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed Volasertib - Leukemia, Myeloid, Acute | Phase 1 | Withdrawn | Boehringer Ingelheim | 2016-11-01 | 2017-01-27 | |
| A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia Volasertib, Idarubicin, Cytarabine - Leukemia, Myeloid, Acute, Leukemia, Monocytic, Acute | Phase 1 | Withdrawn | University of Alberta | 2016-11-01 | 2017-04-05 | |
| Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL Volasertib, Romidepsin - PTCL, CTCL | Phase 1 | Withdrawn | Anne Beaven, MD | 2016-11-01 | 2016-12-01 | |
| Study of Volasertib and Belinostat in Patients With Relapsed and Refractory Aggressive B-cell and T-cell Lymphomas volasertib, belinostat - Relapsed and Refractory Aggressive B- and T-cell Lymphomas, Lymphoma | Phase 1 | Withdrawn | Yale University | 2016-10-01 | 2017-12-22 | |
| Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia Volasertib, Cytarabine, Idarubicin - AML | Phase 1 | Withdrawn | Massachusetts General Hospital | 2016-09-01 | 2018-05-04 | |
| Volasertib and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia Laboratory Biomarker Analysis, Pharmacological Study, Vincristine Sulfate Liposome - Recurrent Adult Acute Lymphoblastic Leukemia, Refractory Adult Acute Lymphoblastic Leukemia | Phase 1 | Withdrawn | Northwestern University | 2016-08-01 | 2016-12-15 | |
| Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes Volasertib, Azacitidine - Myelodysplastic Syndromes | Phase 1 | Terminated | Boehringer Ingelheim | 1 | 2016-04-28 | 2018-08-09 |
| Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) Volasertib, Cytarabine, Daunorubicin - Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS) | Phase 2 | Terminated | University of Ulm | 6 | 2016-02-01 | 2018-02-28 |
| Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Azacitidine, Volasertib - Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic | Phase 1 | Completed | Boehringer Ingelheim | 5 | 2014-08-01 | 2018-07-30 |
| Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML Azacitidine, Volasertib - Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic | Phase 1 | Terminated | Boehringer Ingelheim | 16 | 2013-11-06 | 2019-02-08 |
| Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known volasertib - Leukemia, Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 22 | 2013-10-22 | 2018-07-30 |
| Investigation of Potential Drug-drug Interaction of Volasertib With Itraconazole in Patients With Various Tumours volasertib, itraconazole - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 28 | 2013-02-04 | 2023-09-01 |
| Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2) Placebo, Volasertib, Cytarabine - Leukemia, Myeloid, Acute | Phase 3 | Completed | Boehringer Ingelheim | 666 | 2013-01-29 | 2023-02-08 |
| Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML) Volasertib - Leukemia, Myeloid, Acute | Phase 1 | Completed | Boehringer Ingelheim | 19 | 2012-08-01 | 2018-07-30 |
| BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours Volasertib, low dose, d1q3w, Volasertib, middle dose, d1q3w, Volasertib, high dose, d1q3w - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 15 | 2011-04-25 | 2018-08-06 |
| 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 BI 6727 + BIBW 2992 - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 57 | 2010-10-04 | 2019-02-01 |
| BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours BI 6727 - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 7 | 2010-06-01 | 2019-01-31 |
| BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer Paclitaxel, Gemcitabine, Topotecan - Ovarian Neoplasms | Phase 2 | Completed | Boehringer Ingelheim | 110 | 2010-04-01 | 2015-08-13 |
| Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors BI 6727, BIBF 1120 - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 30 | 2009-12-01 | 2018-07-30 |
| Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer BI 6727, IV infusion - Neoplasms | Phase 2 | Completed | Boehringer Ingelheim | 50 | 2009-11-19 | 2017-11-22 |
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Neoplasms (10) · Leukemia, Myeloid, Acute (6) · Myelodysplastic Syndromes (3) · Leukemia (2) · Leukemia, Myelomonocytic, Chronic (2) · Carcinoma, Non-Small-Cell Lung (1) · Leukemia, Erythroblastic, Acute (1) · Leukemia, Megakaryoblastic, Acute (1) · Leukemia, Monocytic, Acute (1) · Leukemia, Myelomonocytic, Acute (1) · Lymphoma (1) · Lymphoma, T-Cell (1) · Ovarian Neoplasms (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1) · Recurrence (1)
Boehringer Ingelheim (19) · Anne Beaven, MD (1) · Massachusetts General Hospital (1) · Northwestern University (1) · University of Alberta (1) · University of Ulm (1) · Yale University (1)
Belgium (8) · France (5) · Germany (5) · Japan (5) · United States (5) · Canada (4) · Italy (4) · Hungary (3) · Taiwan (3) · Austria (2) · Czechia (2) · Norway (2) · Spain (2) · Argentina (1) · Brazil (1)
Amir T Fathi, MD, PhD (1) · Iris Isufi, MD (1) · Joseph Brandwein, MD (1) · Peter Paschka, MD (1) · Shira Dinner, MD (1) · Steven Gore, MD (1)
PMID 24339028, PMID 25006120, PMID 25794535, PMID 26100229, PMID 26349473, PMID 26627079, PMID 26755507, PMID 33139055, PMID 34646387, PMID 37407274
2008 (3), 2009 (2), 2015 (2), 2005 (1), 2014 (1), P30CA060553 (1)