Trial Outcomes & Findings for Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer (NCT NCT00710710)
NCT ID: NCT00710710
Last Updated: 2022-05-04
Results Overview
Best objective response: Tumour assessment by independent review of tumour imaging by an external contract research organization (CRO) according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.
Results posted on
2022-05-04
Participant Flow
This study was an open, randomised, clinical phase II trial in patients with unresectable advanced pancreatic cancer investigating the efficacy, safety, and pharmacokinetics of BI 2536 administered in repeated 3-week cycles as a single IV dose of 200 mg on Day 1 or as 60 mg doses on Days 1, 2, and 3
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study.
Participant milestones
| Measure |
200mg BI 2536 IV on Day 1
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
Treated
|
43
|
43
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
44
|
Reasons for withdrawal
| Measure |
200mg BI 2536 IV on Day 1
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Overall Study
Consent withdrawn
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Progressive disease
|
40
|
38
|
Baseline Characteristics
Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
63.3 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Quality of Life: Overall health
|
3.8 Score on a scale
STANDARD_DEVIATION 1.21 • n=99 Participants
|
4.1 Score on a scale
STANDARD_DEVIATION 1.31 • n=107 Participants
|
4.0 Score on a scale
STANDARD_DEVIATION 1.26 • n=206 Participants
|
|
Quality of Life: Quality of life
|
3.8 Score on a scale
STANDARD_DEVIATION 1.51 • n=99 Participants
|
4.3 Score on a scale
STANDARD_DEVIATION 1.40 • n=107 Participants
|
4.0 Score on a scale
STANDARD_DEVIATION 1.47 • n=206 Participants
|
PRIMARY outcome
Timeframe: Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline.
Best objective response: Tumour assessment by independent review of tumour imaging by an external contract research organization (CRO) according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=34 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=36 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Confirmed best overall response · Complete response
|
0 Participants
|
0 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Confirmed best overall response · Partial response
|
1 Participants
|
1 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Confirmed best overall response · Stable disease
|
11 Participants
|
10 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Confirmed best overall response · No best response
|
22 Participants
|
25 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Unconfirmed best overall response · Complete response
|
0 Participants
|
0 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Unconfirmed best overall response · Partial response
|
1 Participants
|
2 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Unconfirmed best overall response · Stable disease
|
20 Participants
|
18 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Independent Review
Unconfirmed best overall response · No best response
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Tumour measurements performed at screening (day -21 to -1) and at the end of of the fourth 3-week treatment cycle, up to 105 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline.
Tumour control rate was defined as the number of patients in a treatment arm who had completed 4 courses of treatment and presented with Stable Disease (SD), Partial Response (PR), or Complete Remission (CR). Tumour assessment by independent review of tumour imaging according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum LD since the treatment started. The secondary endpoint "duration of overall response" was integrated into and displayed with tumour control endpoints.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Tumour Control After the Fourth Treatment Course
Tumour control: yes
|
7 Participants
|
4 Participants
|
|
Tumour Control After the Fourth Treatment Course
Tumour control: no
|
14 Participants
|
19 Participants
|
|
Tumour Control After the Fourth Treatment Course
Tumour control: unknown
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.Population: All patients who received at least 1 single dose of BI 2536, who had an evaluation after baseline and who had an unconfirmed best overall response by independent review.
The duration of overall response was measured from the time measurement criteria were met for complete remission (CR) or partial remission (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented, taking as reference for progressive disease the smallest measurements recorded since the treatment started. Tumour assessment by independent review of tumour imaging by an external CRO according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=1 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=2 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Duration of Overall Response
|
42 Days
Standard Deviation NA
Data available for only one subject, dispersion value not calculable.
|
141 Days
Standard Deviation 138.59
|
SECONDARY outcome
Timeframe: Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
Progression free survival (PFS) was defined as the duration of time from randomisation to time of progression or death. For patients without documented progression at the time of analysis, PFS was censored as the total observation time without new anti-cancer therapy. PFS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. Progressive disease: At least a 20% increase in the sum of Longest Diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
47 days
Interval 43.0 to 87.0
|
46 days
Interval 43.0 to 56.0
|
SECONDARY outcome
Timeframe: From first treatment till the end of the trial or when a patient concluded the trial, up to 336 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
Overall survival (OS) was the time from first treatment until death. If there was no occurrence of death or progression until the last follow-up of the trial, the time was to be censored at the date of last trial visit. OS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. The secondary endpoint "One-year survival" was integrated into the secondary endpoint overall survival.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Overall Survival (OS)
|
154 days
Interval 103.0 to 302.0
|
148 days
Interval 81.0 to 315.0
|
SECONDARY outcome
Timeframe: Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 4 patients did not have any evaluations after baseline.
Best objective response: Tumour assessment by investigator assessment of tumour imaging according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=39 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Confirmed best overall response · Complete response
|
0 Participants
|
0 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Confirmed best overall response · Partial response
|
0 Participants
|
0 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Confirmed best overall response · Stable disease
|
11 Participants
|
11 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Confirmed best overall response · No best response
|
28 Participants
|
32 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Unconfirmed best overall response · Complete response
|
0 Participants
|
0 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Unconfirmed best overall response · Partial response
|
0 Participants
|
0 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Unconfirmed best overall response · Stable disease
|
36 Participants
|
38 Participants
|
|
Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment
Unconfirmed best overall response · No best response
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 year, see description for detailed definition of the time frame.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
One-year survival was defined as survival at 1 year after randomisation. For the cohort of first line patients, this time point coincided with the beginning of treatment with the Trial drug. For second line patients, 1 year survival was defined as 1 year after the start of the previous first line treatment for pancreatic cancer.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
One-year Survival
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Blood samples for CA19-9 analysis were collected on Days 1, 2, and 5 of each treatment period, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 19 patients did not have elevated CA19-9 levels at baseline and could not be included.
Number of participants with carbohydrate antigen 19-9 (CA19-9) response rate was defined as the proportion of patients with a decrease in CA19-9 serum levels of ≥25% from baseline in 2 consecutive measurements performed ≥4 weeks apart. Additionally, the proportion of patients with an improved response was assessed, i.e. a decrease in CA19-9 of ≥75% at 2 consecutive measurements ≥4 weeks apart. By definition, a positive CA19-9 response could not occur in patients with normal baseline CA19-9 levels.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response
CA19-9 response · No
|
41 Participants
|
41 Participants
|
|
Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response
CA19-9 response · Yes
|
2 Participants
|
2 Participants
|
|
Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response
Improved CA19-9 response · No
|
43 Participants
|
43 Participants
|
|
Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response
Improved CA19-9 response · Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 1 participants did not experience any adverse event and was not included in the analysis.
Dose limiting toxicity (DLT) was defined as drug-related CTCAE (Common Terminology Criteria for Adverse Events, version 3.0) grade ≥3 non-haematological toxicity (excluding untreated nausea, vomiting or diarrhoea), drug related CTCAE grade 4 neutropenia for ≥7 days and / or complicated by infection of CTCAE grade 4, or drug related CTCAE grade 4 haematological toxicity other than neutropenia.
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=42 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
No
|
32 Participants
|
27 Participants
|
|
Number of Participants With Dose Limiting Toxicity (DLT)
Yes
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline.
Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent).
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=39 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=40 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Quality of Life Assessment, Including Clinical Benefit Response: Overall Health
|
3.8 Score on a scale
Standard Deviation 1.17
|
4.1 Score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline.
Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent).
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=38 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=40 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Quality of Life Assessment, Including Clinical Benefit Response: Quality of Life
|
3.8 Score on a scale
Standard Deviation 1.29
|
4.2 Score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: From first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.Population: Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 1 patient did not experience any AE and was not included in the endpoint.
Number of participants with incidence and intensity of Adverse Events (AE) graded according to CTCAE. Intensity of AEs was scaled according to US-NCI CTCAE, version 3.0. Severity grades 1 to 5 were based on the following general guidelines, with unique clinical descriptions of severity for each AE: * Grade 1 Mild * Grade 2 Moderate * Grade 3 Severe * Grade 4 Life-threatening or disabling * Grade 5 Death
Outcome measures
| Measure |
200mg BI 2536 IV on Day 1
n=43 Participants
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=42 Participants
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE)
Grade 1
|
5 Participants
|
5 Participants
|
|
Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE)
Grade 2
|
7 Participants
|
4 Participants
|
|
Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE)
Grade 3
|
12 Participants
|
16 Participants
|
|
Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE)
Grade 4
|
9 Participants
|
9 Participants
|
|
Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE)
Grade 5
|
10 Participants
|
8 Participants
|
Adverse Events
200mg BI 2536 IV on Day 1
Serious events: 22 serious events
Other events: 41 other events
Deaths: 32 deaths
60mg BI 2536 IV on Day 1-3
Serious events: 23 serious events
Other events: 41 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
200mg BI 2536 IV on Day 1
n=43 participants at risk
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 participants at risk
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Anal fissure
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Ascites
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Duodenitis
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Ileus
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Subileus
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Fatigue
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
General physical health deterioration
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Oedema peripheral
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Pyrexia
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Cholangitis
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Cholestasis
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Hepatic pain
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Immune system disorders
Hypersensitivity
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Anal abscess
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Biliary sepsis
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Infection
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Pneumonia
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Nervous system disorders
Somnolence
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Nervous system disorders
Syncope
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Surgical and medical procedures
Bile duct stent insertion
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Vascular disorders
Hypotension
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Vascular disorders
Lymphoedema
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Vascular disorders
Thrombosis
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
Other adverse events
| Measure |
200mg BI 2536 IV on Day 1
n=43 participants at risk
200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
60mg BI 2536 IV on Day 1-3
n=43 participants at risk
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Blood and lymphatic system disorders
Leukopenia
|
32.6%
14/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
20.9%
9/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.5%
17/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
32.6%
14/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.3%
7/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
14.0%
6/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Ascites
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Constipation
|
30.2%
13/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
23.3%
10/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.3%
10/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
20.9%
9/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.0%
6/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Flatulence
|
23.3%
10/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
16.3%
7/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Nausea
|
30.2%
13/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
41.9%
18/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Gastrointestinal disorders
Vomiting
|
32.6%
14/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Asthenia
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Fatigue
|
39.5%
17/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
53.5%
23/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Oedema peripheral
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Pain
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
General disorders
Pyrexia
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
16.3%
7/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Investigations
Haemoglobin decreased
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Investigations
Weight decreased
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
32.6%
14/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Nervous system disorders
Dizziness
|
18.6%
8/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
11.6%
5/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Psychiatric disorders
Insomnia
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Psychiatric disorders
Sleep disorder
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
14.0%
6/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.0%
6/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
30.2%
13/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.0%
6/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
0.00%
0/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Vascular disorders
Hypertension
|
4.7%
2/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
9.3%
4/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
|
Vascular disorders
Hypotension
|
7.0%
3/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
2.3%
1/43 • from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER