11 completed, 6 withdrawn, 2 terminated. 19 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 19 | Completed 11, Withdrawn 6, Terminated 2 |
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With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed Volasertib - Leukemia, Myeloid, Acute | Phase 1 | Withdrawn | Boehringer Ingelheim | 2016-11-01 | 2017-01-27 | |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Myeloid Leukemia Volasertib, Idarubicin, Cytarabine - Leukemia, Myeloid, Acute, Leukemia, Monocytic, Acute | Phase 1 | Withdrawn | University of Alberta | 2016-11-01 | 2017-04-05 | |
| Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL Volasertib, Romidepsin - PTCL, CTCL | Phase 1 | Withdrawn | Anne Beaven, MD | 2016-11-01 | 2016-12-01 | |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Lymphomas volasertib, belinostat - Relapsed and Refractory Aggressive B- and T-cell Lymphomas, Lymphoma | Phase 1 | Withdrawn | Yale University | 2016-10-01 | 2017-12-22 | |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Combined With Induction Chemotherapy in Acute Myeloid Leukemia Volasertib, Cytarabine, Idarubicin - AML | Phase 1 | Withdrawn | Massachusetts General Hospital | 2016-09-01 | 2018-05-04 | |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Liposome - Recurrent Adult Acute Lymphoblastic Leukemia, Refractory Adult Acute Lymphoblastic Leukemia | Phase 1 | Withdrawn | Northwestern University | 2016-08-01 | 2016-12-15 | |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 |
| 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 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 |
| 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 |
| BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour BI-6727, BI 6727 - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 61 | 2009-08-01 | 2019-01-31 |
| Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers BI 6727 - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 59 | 2009-08-01 | 2019-07-26 |
| BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours BI 6727 - Neoplasms | Phase 1 | Completed | Boehringer Ingelheim | 65 | 2005-11-04 | 2023-10-03 |
Neoplasms (9) · Leukemia, Myeloid, Acute (3) · Myelodysplastic Syndromes (3) · Leukemia (2) · Leukemia, Myelomonocytic, Chronic (2) · Leukemia, Erythroblastic, Acute (1) · Leukemia, Megakaryoblastic, Acute (1) · Leukemia, Monocytic, Acute (1) · Leukemia, Myelomonocytic, Acute (1) · Lymphoma (1) · Lymphoma, T-Cell (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1) · Recurrence (1)
Boehringer Ingelheim (14) · Anne Beaven, MD (1) · Massachusetts General Hospital (1) · Northwestern University (1) · University of Alberta (1) · Yale University (1)
Belgium (5) · Japan (4) · United States (3) · France (2) · Germany (2) · Hungary (2) · Italy (2) · Canada (1) · Czechia (1) · Taiwan (1)
Amir T Fathi, MD, PhD (1) · Iris Isufi, MD (1) · Joseph Brandwein, MD (1) · Shira Dinner, MD (1) · Steven Gore, MD (1)
PMID 25794535, PMID 26349473, PMID 26627079, PMID 33139055
2008 (2), 2015 (2), 2005 (1), 2009 (1), P30CA060553 (1)