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Last Updated: August 4, 2020

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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.
NCT00969761 BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour Completed Boehringer Ingelheim Phase 1 The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin). Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.
NCT01022853 Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors Completed Boehringer Ingelheim Phase 1 The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.
NCT01023958 Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer Completed Boehringer Ingelheim Phase 2 The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
NCT01121406 BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer Completed Boehringer Ingelheim Phase 2 This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer. 100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1. Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727. Others endpoints: biomarkers and pharmacogenetics analysis (optional)
>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
Leukemia, Myelomonocytic, Chronic 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Leukemia 12
Leukemia, Myeloid 8
Leukemia, Myeloid, Acute 8
Preleukemia 4
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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
Germany 5
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Trials by US State

Trials by US State for
Location Trials
Maryland 3
Texas 3
California 3
New York 2
Connecticut 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
University of Ulm 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 21
Other 10
NIH 1
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