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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR VOLASERTIB

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Clinical Trials for Volasertib

Trial ID Title Status Sponsor Phase Summary
NCT00804856 Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia Active, not recruiting Boehringer Ingelheim Phase 2 The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.
NCT00824408 Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC Completed Boehringer Ingelheim Phase 2 The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy. The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.
NCT00969553 Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers Completed Boehringer Ingelheim Phase 1 The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Volasertib

Condition Name

Condition Name for
Intervention Trials
Neoplasms 9
Leukemia, Myeloid, Acute 6
Myelodysplastic Syndromes 3
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Condition MeSH

Condition MeSH for
Intervention Trials
Leukemia 12
Leukemia, Myeloid, Acute 8
Leukemia, Myeloid 8
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Clinical Trial Locations for Volasertib

Trials by Country

Trials by Country for
Location Trials
United States 26
Canada 11
Belgium 7
France 6
Japan 5
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Trials by US State

Trials by US State for
Location Trials
Texas 3
California 3
Maryland 3
Connecticut 2
Virginia 2
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Clinical Trial Progress for Volasertib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 5
Phase 1 19
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 11
Active, not recruiting 4
Not yet recruiting 4
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Clinical Trial Sponsors for Volasertib

Sponsor Name

Sponsor Name for
Sponsor Trials
Boehringer Ingelheim 21
National Comprehensive Cancer Network 2
Anne Beaven, MD 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 21
Other 10
NIH 1
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