Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT01957644
Collaborator
(none)
16
14
3
37.3
1.1
0
Study Details
Study Description
Brief Summary
To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell transplant
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Phase I Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Intravenous Volasertib in Combination With Subcutaneous Azacitidine in Patients With Previously Untreated High-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Not Candidates for Haematopoetic Stem Cell Transplant
Actual Study Start Date
:
Nov 6, 2013
Actual Primary Completion Date
:
Dec 16, 2016
Actual Study Completion Date
:
Dec 16, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Schedule A Volasertib (d1 - one hour iv.) + Azacitidine 75 mg/m2 once daily on Days 1-7 (7 consecutive days) (28-day cycle) |
Drug: Azacitidine
Drug: Volasertib
|
| Experimental: Schedule B Volasertib (d 7 - one hour iv.) + Azacitidine 75 mg/m2 once daily on Days 1-7 (7 consecutive days) (28-day cycle) |
Drug: Azacitidine
Drug: Volasertib
|
| Experimental: Schedule C Volasertib (d 1 and 7 - one hour iv.) + Azacitidine 75 mg/m2 once daily on Days 1-7 (7 consecutive days) (28-day cycle) |
Drug: Azacitidine
Drug: Volasertib
|
Outcome Measures
Primary Outcome Measures
- Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1 [4 weeks]
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1. The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial. Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD.
- Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 [4 weeks]
Number of participants with Dose Limiting Toxicities (DLT) in Cycle 1 (escalation part to determine MTD) is presented .
Secondary Outcome Measures
- Percentage of Patients With Objective Response (OR) [From randomisation until data cut-off (16Dec2016); up to 159 weeks]
OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria. Complete remission (CR): Bone marrow: <5 % myeloblasts with normal maturation of all cell lines* Persistent dysplasia will be noted* Peripheral blood: hemoglobin (Hgb) > 11 Grams Per Decilitre (g/dL) Platelets >100 x 109/L Neutrophils > 1.0 x 109/L Blasts 0 % *Dysplastic changes should consider the normal range of dysplastic changes Partial remission (PR): All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >50% to pre-treatment but still >5% Cellularity and morphology not relevant
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Adult patients with previously untreated, intermediate-2 or high- risk MDS or CMML not eligible for hematopoietic stem cell transplantation (HSCT) based on documented patients characteristics like age, performance status, concomitant diagnoses, and organ dysfunctions
-
Further inclusion criteria apply
Exclusion criteria:
-
Prior or concomitant therapy for higher risk MDS (for example, but not limited to, hypomethylating agents like azacitidine). Note: Prior treatment with erythropoetin (EPO) is allowed up to > 1 week before treatment with study medication. Patients must have not received MDS therapy since diagnosis of higher-risk MDS. However, previous lenalidomide treatment could have been administered for lower-risk MDS treatment as long as this therapy was discontinued at least > 4 weeks before initiation of the current study treatment.
-
Treatment with any investigational drug within 2 weeks before first administration of present trial drug or within less than 5 half lives of the investigational drug before treatment with the present trial drug, whichever is longer.
-
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, e.g. in prostate or breast cancer).
-
Corrected QT interval according to Fridericia (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiograms (ECGs) taken at screening.
-
Total bilirubin > 1.5 x upper limit of normal not related to Gilberts disease, hemolysis, or secondary to MDS.
-
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 x the upper limit of normal (ULN) Creatinine > 1.5 x ULN
-
Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection (hepatitis test results done in routine diagnostics are acceptable if done within 14 days before first study treatment dose).
-
HIV infection (HIV test results in routine diagnostics are acceptable if done within 14 days before first study treatment dose).
-
Severe illness or organ dysfunction involving the kidney, liver or other organ system (e.g. active uncontrolled infection , unstable angina pectoris or history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease), which in the opinion of the investigator would interfere with the evaluation of the safety of the study treatment
-
Further exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1230.33.33002 Boehringer Ingelheim Investigational Site | Marseille | France | ||
| 2 | 1230.33.33001 Boehringer Ingelheim Investigational Site | Paris | France | ||
| 3 | 1230.33.49011 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 4 | 1230.33.49002 Boehringer Ingelheim Investigational Site | Dresden | Germany | ||
| 5 | 1230.33.49001 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany | ||
| 6 | 1230.33.49005 Boehringer Ingelheim Investigational Site | Frankfurt/Main | Germany | ||
| 7 | 1230.33.49004 Boehringer Ingelheim Investigational Site | Freiburg | Germany | ||
| 8 | 1230.33.49010 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 9 | 1230.33.49008 Boehringer Ingelheim Investigational Site | Hannover | Germany | ||
| 10 | 1230.33.49012 Boehringer Ingelheim Investigational Site | Kassel | Germany | ||
| 11 | 1230.33.49014 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 12 | 1230.33.49009 Boehringer Ingelheim Investigational Site | Mannheim | Germany | ||
| 13 | 1230.33.49006 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 14 | 1230.33.49003 Boehringer Ingelheim Investigational Site | Ulm | Germany |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01957644
Other Study ID Numbers:
- 1230.33
- 2013-001290-24
First Posted:
Oct 8, 2013
Last Update Posted:
Feb 8, 2019
Last Verified:
Sep 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The trial had 2 parts. |
|---|---|
| Pre-assignment Detail | Part 1:Starting dose of volasertib 250 mg administered on Day1 and Day15.The dose was escalated in 50 mg steps up to 300 mg.Flat dosing in Part 1. Part 2:volasertib dosing on Day1 in schedule A, on Day7 in schedule B, on Day1+ Day7 in schedule C.Body surface area (BSA) adapted dosing in Part 2. In each cycle, azacitidine was given from Day1 to 7 |
| Arm/Group Title | Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 |
|---|---|---|---|---|---|
| Arm/Group Description | Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle) | Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort | Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) |
| Period Title: Overall Study | |||||
| STARTED | 6 | 6 | 1 | 2 | 1 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 6 | 6 | 1 | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle) | Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort | Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Total of all reporting groups |
| Overall Participants | 6 | 6 | 1 | 2 | 1 | 16 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
69.5
(8.2)
|
69.2
(7.7)
|
60.0
(NA)
|
64.5
(13.4)
|
81.0
(NA)
|
68.9
(8.5)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
1
16.7%
|
1
16.7%
|
0
0%
|
0
0%
|
1
100%
|
3
18.8%
|
| Male |
5
83.3%
|
5
83.3%
|
1
100%
|
2
100%
|
0
0%
|
13
81.3%
|
Outcome Measures
| Title | Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1 |
|---|---|
| Description | The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1. The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial. Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD. |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| MTD set: The MTD set was used for the first treatment cycle (Cycle 1) analysis and excluded any treated patients that missed any dose of trial medication in Cycle 1 for reasons other than DLT |
| Arm/Group Title | Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 |
|---|---|---|---|---|
| Arm/Group Description | Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle) | Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) |
| Measure Participants | 6 | 5 | 1 | 1 |
| Number [Milligram (mg)] |
NA
|
NA
|
NA
|
NA
|
| Title | Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 |
|---|---|
| Description | Number of participants with Dose Limiting Toxicities (DLT) in Cycle 1 (escalation part to determine MTD) is presented . |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| MTD set |
| Arm/Group Title | Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 |
|---|---|---|---|---|
| Arm/Group Description | Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle) | Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) |
| Measure Participants | 6 | 5 | 1 | 1 |
| Number [participants] |
1
16.7%
|
1
16.7%
|
0
0%
|
1
50%
|
| Title | Percentage of Patients With Objective Response (OR) |
|---|---|
| Description | OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria. Complete remission (CR): Bone marrow: <5 % myeloblasts with normal maturation of all cell lines* Persistent dysplasia will be noted* Peripheral blood: hemoglobin (Hgb) > 11 Grams Per Decilitre (g/dL) Platelets >100 x 109/L Neutrophils > 1.0 x 109/L Blasts 0 % *Dysplastic changes should consider the normal range of dysplastic changes Partial remission (PR): All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >50% to pre-treatment but still >5% Cellularity and morphology not relevant |
| Time Frame | From randomisation until data cut-off (16Dec2016); up to 159 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy set (ES): All the treated patients without any protocol violations related to efficacy |
| Arm/Group Title | Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 |
|---|---|---|---|---|---|
| Arm/Group Description | Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle) | Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort | Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) |
| Measure Participants | 6 | 5 | 1 | 2 | 1 |
| Number [percentage of participants] |
33.3
555%
|
20.0
333.3%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
Adverse Events
| Time Frame | From randomisation until data cut-off (16Dec2016); up to 159 weeks | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | |||||
| Arm/Group Description | Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle) | Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort | Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) | |||||
All Cause Mortality |
||||||||||
| Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 2/6 (33.3%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Febrile neutropenia | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| General disorders | ||||||||||
| Chest pain | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| General physical health deterioration | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Systemic inflammatory response syndrome | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholecystitis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Infections and infestations | ||||||||||
| Anal abscess | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Pneumonia | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Sepsis | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| Skin infection | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Urosepsis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Investigations | ||||||||||
| Blood creatinine increased | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| C-reactive protein increased | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hypokalaemia | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Osteonecrosis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 5/6 (83.3%) | 1/1 (100%) | 2/2 (100%) | 1/1 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 1/6 (16.7%) | 2/6 (33.3%) | 1/1 (100%) | 1/2 (50%) | 0/1 (0%) | |||||
| Cyclic neutropenia | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Leukopenia | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Neutropenia | 3/6 (50%) | 3/6 (50%) | 1/1 (100%) | 1/2 (50%) | 1/1 (100%) | |||||
| Thrombocytopenia | 4/6 (66.7%) | 5/6 (83.3%) | 1/1 (100%) | 1/2 (50%) | 1/1 (100%) | |||||
| Cardiac disorders | ||||||||||
| Cardiac valve disease | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Cardiovascular disorder | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Coronary artery stenosis | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Mitral valve incompetence | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Endocrine disorders | ||||||||||
| Thyroid mass | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Eye disorders | ||||||||||
| Eye haemorrhage | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Scleral haemorrhage | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Vision blurred | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain | 0/6 (0%) | 1/6 (16.7%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Abdominal pain upper | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Constipation | 3/6 (50%) | 2/6 (33.3%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Diarrhoea | 2/6 (33.3%) | 3/6 (50%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Mouth haemorrhage | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Nausea | 3/6 (50%) | 2/6 (33.3%) | 0/1 (0%) | 2/2 (100%) | 0/1 (0%) | |||||
| Neutropenic colitis | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Oral dysaesthesia | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Proctalgia | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Stomatitis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Vomiting | 2/6 (33.3%) | 1/6 (16.7%) | 1/1 (100%) | 1/2 (50%) | 0/1 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Chest pain | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Chills | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Fatigue | 3/6 (50%) | 2/6 (33.3%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Feeling cold | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| General physical health deterioration | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 1/1 (100%) | |||||
| Inflammation | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Injection site pain | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Oedema | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Oedema peripheral | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Peripheral swelling | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Pyrexia | 2/6 (33.3%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatic lesion | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Infections and infestations | ||||||||||
| Fungal skin infection | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Haematoma infection | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Infected bite | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Infection | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Influenza | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Nasopharyngitis | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Oral candidiasis | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Oral herpes | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Paronychia | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Pneumonia | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Respiratory tract infection | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Skin infection | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Tooth infection | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Urinary tract infection | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Allergic transfusion reaction | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Limb injury | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Post procedural haemorrhage | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Subcutaneous haematoma | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Thermal burn | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Tooth avulsion | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Investigations | ||||||||||
| Blood creatine increased | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Blood creatine phosphokinase increased | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Blood creatinine increased | 2/6 (33.3%) | 1/6 (16.7%) | 1/1 (100%) | 1/2 (50%) | 1/1 (100%) | |||||
| Blood folate decreased | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Body temperature increased | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| C-reactive protein increased | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Ejection fraction decreased | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Electrocardiogram QT prolonged | 0/6 (0%) | 1/6 (16.7%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Neutrophil count decreased | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Weight decreased | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 2/6 (33.3%) | 3/6 (50%) | 1/1 (100%) | 0/2 (0%) | 1/1 (100%) | |||||
| Dehydration | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Diabetes mellitus | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hyperglycaemia | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hyperkalaemia | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hypokalaemia | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| Hypomagnesaemia | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| Hyponatraemia | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hypophosphataemia | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 1/1 (100%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Back pain | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 1/2 (50%) | 0/1 (0%) | |||||
| Growing pains | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Joint swelling | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Muscular weakness | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Musculoskeletal pain | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Osteonecrosis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Nervous system disorders | ||||||||||
| Ataxia | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Dizziness | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Headache | 0/6 (0%) | 0/6 (0%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Depression | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Libido disorder | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Sleep disorder | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Haematuria | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Renal disorder | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Urinary incontinence | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Urinary tract obstruction | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 2/6 (33.3%) | 3/6 (50%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Dyspnoea | 0/6 (0%) | 2/6 (33.3%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Epistaxis | 2/6 (33.3%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Lung disorder | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Sneezing | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 1/6 (16.7%) | 3/6 (50%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Dermatitis | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Erythema | 1/6 (16.7%) | 2/6 (33.3%) | 1/1 (100%) | 0/2 (0%) | 0/1 (0%) | |||||
| Nail bed inflammation | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Night sweats | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Petechiae | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Rash | 4/6 (66.7%) | 1/6 (16.7%) | 1/1 (100%) | 1/2 (50%) | 0/1 (0%) | |||||
| Rash maculo-papular | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Rash pruritic | 0/6 (0%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
| Skin lesion | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Vascular disorders | ||||||||||
| Arteriosclerosis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Flushing | 0/6 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Haematoma | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Hypertension | 1/6 (16.7%) | 1/6 (16.7%) | 0/1 (0%) | 0/2 (0%) | 0/1 (0%) | |||||
| Thrombophlebitis | 1/6 (16.7%) | 0/6 (0%) | 0/1 (0%) | 1/2 (50%) | 0/1 (0%) | |||||
Limitations/Caveats
The sponsor discontinued the development of volasertib on 25 Nov 2016 and this trial was discontinued on 16 Dec 2016 for non-clinical reasons. The number of patients enrolled in Part 2 of the study was too small for a meaningful analysis.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title | Boehringer Ingelheim, Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01957644
Other Study ID Numbers:
- 1230.33
- 2013-001290-24
First Posted:
Oct 8, 2013
Last Update Posted:
Feb 8, 2019
Last Verified:
Sep 1, 2018