NCT00804856 is a Phase 2 clinical trial of Volasertib in Leukemia, Myeloid, Acute, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT00804856?

NCT00804856 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT00804856?

Interventions in NCT00804856: Volasertib, Cytarabine.

What condition does NCT00804856 study?

NCT00804856 studies Leukemia, Myeloid, Acute.

Is NCT00804856 still recruiting?

NCT00804856 is currently completed. Last updated 3 October 2023.

Are results published for NCT00804856?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-03 · How we verify

NCT00804856

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

Completed Phase 2 Results posted Last updated 3 October 2023

What this trial tests

Phase 2 trial testing Volasertib in Leukemia, Myeloid, Acute in 180 participants. Completed in 23 April 2021.

Timeline

27 November 2008

Primary endpoint
9 March 2012

23 April 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	27 November 2008
Primary completion	9 March 2012
Estimated completion	23 April 2021
Sites	27 locations across France, Italy, Belgium, Austria, Germany, Norway, Canada

Drugs / interventions tested

Volasertib — full drug profile →
Cytarabine — full drug profile →

Conditions studied

Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase I: Maximum Tolerated Dose (MTD) of Volasertib in Combination With LDAC (Schedule A) and Volasertib Monotherapy (Schedule B) Primary · First Treatment cycle, up to 28 days.

To determine the Maximum tolerated dose (MTD), dose escalation was conducted following the 3+3 design with de-escalation. The MTD was defined as the highest dose at which 6 patients had been treated and less than 2 patients experienced a Dose limiting toxicity (DLT) within the first cycle of treatment. The MTD was defined based on safety data from the first cycle only. DLT is defined as drug related Common terminology criteria for adverse events (CTCAE) grade ≥ 3 nonhaematological toxicity (excluding: untreated nausea, untreated vomiting, CTCAE grade 3 untreated diarrhoea, CTCAE grade 3 "febr

Group	Value	95% CI
Phase I Schedule A. Volasertib+LDAC	350
Phase I Schedule B. Volasertib	450

Phase II: Number of Patients With Objective Response (Complete Remission (CR) + Complete Remission With Incomplete Blood Count Recovery (CRi)) Primary · The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.

Phase II: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)). Complete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \>100,000/μL. Complete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \<1,000/μL or platelets \<100,000/μL in the blo

Group	Value	95% CI
Phase II Schedule C. LDAC	6
Phase II Schedule A. Volasertib 350 mg+LDAC	13

Phase I: Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) Primary · First Treatment cycle, up to 28 days.

A DLT was defined as a drug related CTCAE (Common Toxicity Criteria for Adverse Events) Grade ≥3 non-haematological toxicity (excluding untreated nausea, untreated vomiting, Grade 3 untreated diarrhea, Grade 3 febrile neutropenia, and Grade 3 infection with Grade 3 or 4 neutrophils). In patients with CRi (Complete Remission with Incomplete Blood Count Recovery) or PR (Partial Remission), persistent Grade 4 neutropenia or thrombocytopenia for 3 weeks after the end of the treatment cycle was regarded as a DLT unless the respective Grade 4 cytopenia was preexistent. In patients who required plate

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	1
Phase I Schedule A. Volasertib 350 mg+LDAC	1
Phase I Schedule A. Volasertib 400 mg+LDAC	2
Total Phase I Combined. Schedule A.	4
Phase I Schedule B. Volasertib 150 mg	1
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	0
Phase I Schedule B. Volasertib 400 mg	1
Phase I Schedule B. Volasertib 450 mg	1

Best Overall Response Secondary · The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.

* CR * CR+CRi * Partial remission: CR except bone marrow (BM) contained ≥5% but \<25% blasts (or ≤50% initial blasts), or \<5% blasts in presence of Auer rods or abnormal morphology. * No change: survived ≥7 days (d) after 1st cycle with persistent leukemia in last peripheral blood smear or BM, or with persistent extramedullary disease, without further deterioration due to leukemia or increase of blasts in BM or peripheral blood. * Aplasia: survived ≥7d after 1st cycle, died whilst cytopenic, with last post-treatment BM result aplastic or hypoplastic and without leukemia blasts. * Indeterminat

Complete remission

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	2
Phase I Schedule A. Volasertib 300 mg+LDAC	0
Phase I Schedule A. Volasertib 350 mg+LDAC	0
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	2
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	0
Phase I Schedule B. Volasertib 400 mg	0
Phase I Schedule B. Volasertib 450 mg	0

CRi

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	2
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	1
Phase I Schedule A. Volasertib 350 mg+LDAC	1
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	4
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	1
Phase I Schedule B. Volasertib 400 mg	2
Phase I Schedule B. Volasertib 450 mg	2

Partial remission

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	0
Phase I Schedule A. Volasertib 350 mg+LDAC	0
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	0
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	1
Phase I Schedule B. Volasertib 400 mg	0
Phase I Schedule B. Volasertib 450 mg	2

No change

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	2
Phase I Schedule A. Volasertib 200 mg+LDAC	1
Phase I Schedule A. Volasertib 250 mg+LDAC	2
Phase I Schedule A. Volasertib 300 mg+LDAC	1
Phase I Schedule A. Volasertib 350 mg+LDAC	1
Phase I Schedule A. Volasertib 400 mg+LDAC	1
Total Phase I Combined. Schedule A.	8
Phase I Schedule B. Volasertib 150 mg	4
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	2
Phase I Schedule B. Volasertib 400 mg	2
Phase I Schedule B. Volasertib 450 mg	7

Aplasia

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	0
Phase I Schedule A. Volasertib 350 mg+LDAC	0
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	0
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	0
Phase I Schedule B. Volasertib 400 mg	1
Phase I Schedule B. Volasertib 450 mg	3

Indeterminate

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	2
Phase I Schedule A. Volasertib 350 mg+LDAC	3
Phase I Schedule A. Volasertib 400 mg+LDAC	1
Total Phase I Combined. Schedule A.	6
Phase I Schedule B. Volasertib 150 mg	1
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	0
Phase I Schedule B. Volasertib 400 mg	0
Phase I Schedule B. Volasertib 450 mg	0

Progressive disease

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	2
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	1
Phase I Schedule A. Volasertib 300 mg+LDAC	3
Phase I Schedule A. Volasertib 350 mg+LDAC	3
Phase I Schedule A. Volasertib 400 mg+LDAC	1
Total Phase I Combined. Schedule A.	10
Phase I Schedule B. Volasertib 150 mg	6
Phase I Schedule B. Volasertib 200 mg	2
Phase I Schedule B. Volasertib 350 mg	1
Phase I Schedule B. Volasertib 400 mg	1
Phase I Schedule B. Volasertib 450 mg	7

Not evaluable

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	1
Phase I Schedule A. Volasertib 350 mg+LDAC	0
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	1
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	0
Phase I Schedule B. Volasertib 400 mg	0
Phase I Schedule B. Volasertib 450 mg	2

Phase I: Number of Patients With Objective Response: Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR+CRi) Secondary · The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 594 days.

Phase I: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)). Complete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \>100,000/μL. Complete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \<1,000/μL or platelets \<100,000/μL in the bloo

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	2
Phase I Schedule A. Volasertib 250 mg+LDAC	2
Phase I Schedule A. Volasertib 300 mg+LDAC	1
Phase I Schedule A. Volasertib 350 mg+LDAC	1
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	6
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	1
Phase I Schedule B. Volasertib 400 mg	2
Phase I Schedule B. Volasertib 450 mg	2

Phase II: Event Free Survival Secondary · The patients that entered the trial, and measured from the date of randomization to the date of disease progression (treatment failure), relapse or death from any cause, whichever occurred first, up to 1000 days..

Event-free survival (EFS) \[days\] was the shortest duration of the following: (a) Date of assessment indicating PD on the response page of the eCRF (Electronic Case Report Form) - date of randomisation + 1 day (b) Date of assessment indicating clinical progressive disease (PD) on the disease or responses pages of the of eCRF- date of randomisation + 1 day (c) Date of assessment indicating PD on the patient status page of the eCRF - date of randomisation +1 day (for patients who had not been censored before this time point) (d) Death date - date of randomisation +1 day Patients not being asses

Group	Value	95% CI
Phase II Schedule C. LDAC	69.0	27 – 215
Phase II Schedule A. Volasertib 350 mg+LDAC	169.0	39 – 470

Phase II: Overall Survival Secondary · The patients that entered the trial, and measured from the date of randomisation until death from any cause, up to 1100 days..

Overall survival \[days\] = (date of death - date of randomisation + 1 day), for patients with known date of death. Overall survival (censored) \[days\] = (date of last trial visit or follow-up - date of randomisation + 1 day), for patients who were still alive at time of database lock. Overall survival (OS) was analysed with the Kaplan-Meier method for each of the treatment arms.

Group	Value	95% CI
Phase II Schedule C. LDAC	158.0	78 – 347
Phase II Schedule A. Volasertib 350 mg+LDAC	245.0	73 – 689

Phase II: Relapse - Free Survival Secondary · The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence or death from any cause, whichever occurred first, up to 900 days.

Relapse-free survival \[days\] = (date of first recurrence of disease or death after entering the trial - date of first occurrence of CR or CRi after entering the trial+ 1 day) for patients with a recurrence (this value should be positive). Relapse-free survival (censored) \[days\] = (date of last trial visit or follow-up - date of first occurrence of CR or CRi after entering the trial + 1 day) for patients who did not experience recurrence of disease or death at the time of analysis.

Group	Value	95% CI
Phase II Schedule C. LDAC	304.0	113 – 367
Phase II Schedule A. Volasertib 350 mg+LDAC	563.0	427 – NA

Phase II: Remission Duration Secondary · The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 900 days.

Remission duration analysis was defined only for patients who achieved Complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of cause.

Group	Value	95% CI
Phase II Schedule C. LDAC	367.0	113 – 367
Phase II Schedule A. Volasertib 350 mg+LDAC	687.0	427 – NA

Phase II: Time to Remission Secondary · The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 158 days.

Time to remission \[days\] = (date of first occurrence of CR or CRi after entering the trial-date of randomisation + 1 day) for patients with an objective response.

Group	Value	95% CI
Phase II Schedule C. LDAC	63.5	30 – 125
Phase II Schedule A. Volasertib 350 mg+LDAC	71.0	29 – 158

Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment Secondary · Baseline and End of Treatment (up to 869 days).

ECOG performance score change from baseline to last visit of last cycle = ECOG performance score at last visit of the last cycle - ECOG performance score at baseline. ECOG performance score changes from baseline were also categorised on a 3-point categorical scale: deteriorated (-1), unchanged (0), and improved (1). The number of participants for category of ECOG score change is reported.

Unchanged

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	3
Phase I Schedule A. Volasertib 200 mg+LDAC	1
Phase I Schedule A. Volasertib 250 mg+LDAC	5
Phase I Schedule A. Volasertib 300 mg+LDAC	2
Phase I Schedule A. Volasertib 350 mg+LDAC	5
Phase I Schedule A. Volasertib 400 mg+LDAC	1
Total Phase I Combined. Schedule A.	17
Phase I Schedule B. Volasertib 150 mg	9
Phase I Schedule B. Volasertib 200 mg	1
Phase I Schedule B. Volasertib 350 mg	0
Phase I Schedule B. Volasertib 400 mg	4
Phase I Schedule B. Volasertib 450 mg	14

Improved

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	0
Phase I Schedule A. Volasertib 200 mg+LDAC	2
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	1
Phase I Schedule A. Volasertib 350 mg+LDAC	0
Phase I Schedule A. Volasertib 400 mg+LDAC	0
Total Phase I Combined. Schedule A.	3
Phase I Schedule B. Volasertib 150 mg	0
Phase I Schedule B. Volasertib 200 mg	0
Phase I Schedule B. Volasertib 350 mg	1
Phase I Schedule B. Volasertib 400 mg	1
Phase I Schedule B. Volasertib 450 mg	3

Deteriorated

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	1
Phase I Schedule A. Volasertib 200 mg+LDAC	0
Phase I Schedule A. Volasertib 250 mg+LDAC	0
Phase I Schedule A. Volasertib 300 mg+LDAC	2
Phase I Schedule A. Volasertib 350 mg+LDAC	3
Phase I Schedule A. Volasertib 400 mg+LDAC	1
Total Phase I Combined. Schedule A.	7
Phase I Schedule B. Volasertib 150 mg	1
Phase I Schedule B. Volasertib 200 mg	1
Phase I Schedule B. Volasertib 350 mg	4
Phase I Schedule B. Volasertib 400 mg	1
Phase I Schedule B. Volasertib 450 mg	5

Total Clearance (CL) of Volasertib in Plasma After i.v (Intravenous) Administration of Volasertib Secondary · Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.

Total Clearance (CL) of Volasertib in Plasma after Intravenous (i.v.) Administration of Volasertib.

Group	Value	95% CI
Phase I Schedule A. Volasertib 150 mg+LDAC	1280	± 52.8
Phase I Schedule A. Volasertib 200 mg+LDAC	972	± 26.6
Phase I Schedule A. Volasertib 250 mg+LDAC	864	± 27.6
Phase I Schedule A. Volasertib 300 mg+LDAC	1150	± 34.4
Phase I Schedule A. Volasertib 350 mg+LDAC	1000	± 36.2
Phase I Schedule A. Volasertib 400 mg+LDAC	852	± 49.6
Phase I Schedule B. Volasertib 150 mg	1330	± 29.3
Phase I Schedule B. Volasertib 200 mg	NA	± NA
Phase I Schedule B. Volasertib 350 mg	810	± 35.1
Phase I Schedule B. Volasertib 400 mg	1120	± 62.1
Phase I Schedule B. Volasertib 450 mg	920	± 36.2
Phase I Schedule B. Volasertib 500 mg	1140	± 38.5

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase II Schedule C. LDAC

Serious: 29/45 (64%)

Deaths: 45/45

Phase I Schedule A. Volasertib 150 mg+LDAC

Serious: 2/4 (50%)

Deaths: 4/4

Phase I Schedule A. Volasertib 200 mg+LDAC

Serious: 3/3 (100%)

Deaths: 3/3

Phase I Schedule A. Volasertib 250 mg+LDAC

Serious: 3/5 (60%)

Deaths: 4/5

Phase I Schedule A. Volasertib 300 mg+LDAC

Serious: 7/9 (78%)

Deaths: 9/9

Phase I Schedule A. Volasertib 350 mg+LDAC

Serious: 6/8 (75%)

Deaths: 8/8

Phase II Schedule A. Volasertib 350 mg+LDAC

Serious: 34/42 (81%)

Deaths: 38/42

Phase I Schedule A. Volasertib 400 mg+LDAC

Serious: 3/3 (100%)

Deaths: 3/3

Phase I Schedule B. Volasertib 150 mg

Serious: 7/11 (64%)

Deaths: 11/11

Phase I Schedule B. Volasertib 200 mg

Serious: 1/2 (50%)

Deaths: 2/2

Phase I Schedule B. Volasertib 350 mg

Serious: 3/5 (60%)

Deaths: 3/5

Phase I Schedule B. Volasertib 400 mg

Serious: 3/6 (50%)

Deaths: 6/6

Phase I Schedule B. Volasertib 450 mg

Serious: 16/23 (70%)

Deaths: 21/23

Phase I Schedule B. Volasertib 500 mg

Serious: 3/5 (60%)

Deaths: 5/5

Phase I Schedule B. Volasertib 550 mg

Serious: 3/4 (75%)

Deaths: 4/4

Serious adverse events (132 terms)

Reaction	System	Phase II Schedule C. LDAC	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase II Schedule A. Volas…	Phase I Schedule A. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Escherichia sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia fungal	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subdural haematoma	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary retention	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bone marrow failure	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile bone marrow aplasia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (417 terms — click to expand)

Reaction	System	Phase II Schedule C. LDAC	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase I Schedule A. Volase…	Phase II Schedule A. Volas…	Phase I Schedule A. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…	Phase I Schedule B. Volase…
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Pyrexia, Pneumonia, Anaemia, Thrombocytopenia, General physical health deterioration, Sepsis, C-reactive protein increased.

Data from ClinicalTrials.gov NCT00804856 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cell cycle proteins as promising targets in cancer therapy.
Otto T, Sicinski P. · · 2017 · cited 1412× · PMID 28127048 · DOI 10.1038/nrc.2016.138
Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy.
Döhner H, Lübbert M, Fiedler W, Fouillard L, et al · · 2014 · cited 186× · PMID 25006120 · DOI 10.1182/blood-2014-03-560557
Discovery and development of the Polo-like kinase inhibitor volasertib in cancer therapy.
Gjertsen BT, Schöffski P. · · 2015 · cited 173× · PMID 25027517 · DOI 10.1038/leu.2014.222
The two sides of chromosomal instability: drivers and brakes in cancer.
Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
Present and Future Perspective on PLK1 Inhibition in Cancer Treatment.
Chiappa M, Petrella S, Damia G, Broggini M, et al · · 2022 · cited 95× · PMID 35719948 · DOI 10.3389/fonc.2022.903016
The balance between mitotic death and mitotic slippage in acute leukemia: a new therapeutic window?
Ghelli Luserna di Rorà A, Martinelli G, Simonetti G. · · 2019 · cited 40× · PMID 31771633 · DOI 10.1186/s13045-019-0808-4
Second-Generation Antimitotics in Cancer Clinical Trials.
Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
The rocky road to personalized medicine in acute myeloid leukaemia.
Brinda B, Khan I, Parkin B, Konig H. · · 2018 · cited 15× · PMID 29327808 · DOI 10.1111/jcmm.13478

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00804856 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 3 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00804856.

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NCT00804856

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (132 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Volasertib

Other recruiting trials for Leukemia, Myeloid, Acute

Other Boehringer Ingelheim trials

Verify against primary sources