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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023832-18 | EudraCT Number | EudraCT |
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The aim of the Phase Ia (dose escalation) part of this trial is to assess the maximum tolerated dose (MTD) of BI 847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part of the trial, the aim is to further evaluate the safety profile of BI 847325 at the recommended dose and schedule and to assess target modulation and the potential antitumour efficacy in patients with selected tumour types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm A | Experimental | 14 days once a day oral intake of BI 847325 followed by 7 days break in 3-week cycles |
|
| arm B | Experimental | 5 days once daily oral intake of BI 847325 followed by 2 days break, repeated every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| day 1 to day 5 | Drug | low to high dose |
| |
| day 1 to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Dose Limiting Toxicity During the First Treatment Cycle in Phase Ia Part of the Study | Occurrence of dose limiting toxicity (DLT) during the first treatment cycle for the treatment Schedules A and B. Some patients excluded from Treated Set (TS) as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Best overall response was the best response a patient experienced during their time on study from the start of treatment until: disease progression, the last evaluable assessment in the absence of progression, or the start of subsequent anti-cancer therapy. Death was not considered as progressive disease when determining best overall response; patients who died prior to an evaluable imaging assessment were reported as not evaluable. Some patients were excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. |
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Inclusion criteria:
Patients with a histologically or cytologically confirmed diagnosis of an advanced unresectable and/or metastatic solid tumour, and who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to standard therapies.
Age 18 years and older
Written informed consent consistent with International conference on harmonization - Good clinical practice (ICH-GCP) and local legislation
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Recovery of therapy-related toxicities from previous anti-tumour therapies to Common Terminology Criteria for Adverse Events (CTCAE) = grade 1 (with the exception of alopecia).
Written informed consent to the use of archival tumour sample for determination of the BRAF/Tat sarcoma viral oncogene homolog (RAS) mutational status.
Life expectancy of at least 12 weeks.
In escalation phase, when pharmacokinetic (PK) close to predicted Cmax or when signs of progressive disease (PD) modulation present, optional tumour biopsies (at same timepoints as in expansion phase) for the patients who consented to it.
In addition, all patients included in the expansion phase (part Ib) must:
have been diagnosed with one of the following tumours: melanoma, colorectal carcinoma, Non Small Cell Lung Cancer (NSCLC) or exocrine pancreas adenocarcinoma, and have been shown on their archival tumour sample to have KRAS or BRAF mutation.
have a measurable disease.
have documented/proven progressive disease within the last 6 months, according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria
11. have a tumour lesion accessible for biopsies (pre- and post-treatment): this is mandatory for patients with colorectal carcinoma or melanoma, optional for patients with NSCLC or exocrine pancreas adenocarcinoma.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1287.1.3201 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||||
| 1287.1.3202 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Schedule A BI 847325 6 mg (A1) | Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG001 | Schedule A BI 847325 9 mg (A2) | Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG002 | Schedule A BI 847325 13 mg (A3) | Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG003 | Schedule A BI 847325 19 mg (A4) | Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG004 | Schedule A BI 847325 26 mg (A5) | Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG005 | Schedule A BI 847325 33 mg (A6) | Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG006 | Schedule A BI 847325 46 mg (A7) | Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG007 | Schedule A BI 847325 63 mg (A8) | Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG008 | Schedule A BI 847325 86 mg (A9) | Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG009 | Schedule A BI 847325 120 mg (A10) | Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG010 | Schedule A BI 847325 160 mg (A11) | Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG011 | Schedule B BI 847325 6 mg (B1) | Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG012 | Schedule B BI 847325 12 mg (B2) | Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG013 | Schedule B BI 847325 23 mg (B3) | Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG014 | Schedule B BI 847325 46 mg (B4) | Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG015 | Schedule B BI 847325 90 mg (B5) | Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG016 | Schedule B BI 847325 180 mg (B6) | Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG017 | Schedule B BI 847325 130 mg (B7) | Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| FG018 | Schedule B BI 847325 150 mg (B8) | Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): included all patients who were documented to have received and taken at least one BI 847325 dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | Schedule A BI 847325 6 mg (A1) | Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG001 | Schedule A BI 847325 9 mg (A2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Dose Limiting Toxicity During the First Treatment Cycle in Phase Ia Part of the Study | Occurrence of dose limiting toxicity (DLT) during the first treatment cycle for the treatment Schedules A and B. Some patients excluded from Treated Set (TS) as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | Treated Set (TS) | Posted | Number | Percentage of participants | 3 weeks |
|
From the start date of trial medication up to 21 days after the last administration of BI 847325, up to 266 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Schedule A BI 847325 6 mg (A1) | Schedule A BI 847325 6 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
As the trial was terminated without commencing Phase Ib, the endpoints of progression-free survival, time to objective response, duration of objective response and duration of disease control were specified as further endpoints for Phase Ia.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Drug |
low to high dose |
|
| From the start of treatment until the last evaluable assessment. The data cut-off date is 29-Nov-2013 |
| Objective Response | Objective response was a best overall response of complete or partial response, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment. Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | From the start of treatment and the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013. |
| Disease Control | Disease control was a best overall response of complete response, partial response or stable disease, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment. Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | From the start of treatment to the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013. |
| Leuven |
| Belgium |
| Dose limiting toxicity |
|
| Reason not mentioned above |
|
| Adverse Event, serious fatal |
|
| Adverse Event, non-fatal |
|
| Withdrawal by Subject |
|
Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG002 | Schedule A BI 847325 13 mg (A3) | Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG003 | Schedule A BI 847325 19 mg (A4) | Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG004 | Schedule A BI 847325 26 mg (A5) | Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG005 | Schedule A BI 847325 33 mg (A6) | Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG006 | Schedule A BI 847325 46 mg (A7) | Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG007 | Schedule A BI 847325 63 mg (A8) | Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG008 | Schedule A BI 847325 86 mg (A9) | Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG009 | Schedule A BI 847325 120 mg (A10) | Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG010 | Schedule A BI 847325 160 mg (A11) | Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG011 | Schedule B BI 847325 6 mg (B1) | Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG012 | Schedule B BI 847325 12 mg (B2) | Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG013 | Schedule B BI 847325 23 mg (B3) | Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG014 | Schedule B BI 847325 46 mg (B4) | Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG015 | Schedule B BI 847325 90 mg (B5) | Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG016 | Schedule B BI 847325 180 mg (B6) | Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG017 | Schedule B BI 847325 130 mg (B7) | Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG018 | Schedule B BI 847325 150 mg (B8) | Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| BG019 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Schedule A BI 847325 9 mg (A2) |
Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG002 | Schedule A BI 847325 13 mg (A3) | Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG003 | Schedule A BI 847325 19 mg (A4) | Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG004 | Schedule A BI 847325 26 mg (A5) | Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG005 | Schedule A BI 847325 33 mg (A6) | Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG006 | Schedule A BI 847325 46 mg (A7) | Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG007 | Schedule A BI 847325 63 mg (A8) | Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG008 | Schedule A BI 847325 86 mg (A9) | Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG009 | Schedule A BI 847325 120 mg (A10) | Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG010 | Schedule A BI 847325 160 mg (A11) | Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG011 | Schedule B BI 847325 6 mg (B1) | Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG012 | Schedule B BI 847325 12 mg (B2) | Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG013 | Schedule B BI 847325 23 mg (B3) | Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG014 | Schedule B BI 847325 46 mg (B4) | Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG015 | Schedule B BI 847325 90 mg (B5) | Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG016 | Schedule B BI 847325 180 mg (B6) | Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG017 | Schedule B BI 847325 130 mg (B7) | Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG018 | Schedule B BI 847325 150 mg (B8) | Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. |
| OG019 | Schedule A Total (Total A) | All patients with schedule A. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. |
| OG020 | Schedule B Total (Total B) | Schedule B total treated patients. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. |
| OG021 | Total Patients | Schedule A and B total patients. |
|
|
| Secondary | Best Overall Response | Best overall response was the best response a patient experienced during their time on study from the start of treatment until: disease progression, the last evaluable assessment in the absence of progression, or the start of subsequent anti-cancer therapy. Death was not considered as progressive disease when determining best overall response; patients who died prior to an evaluable imaging assessment were reported as not evaluable. Some patients were excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | TS | Posted | Number | Participants | From the start of treatment until the last evaluable assessment. The data cut-off date is 29-Nov-2013 |
|
|
|
| Secondary | Objective Response | Objective response was a best overall response of complete or partial response, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment. Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | TS | Posted | Number | Participants | From the start of treatment and the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013. |
|
|
|
| Secondary | Disease Control | Disease control was a best overall response of complete response, partial response or stable disease, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment. Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients. | TS | Posted | Number | Participants | From the start of treatment to the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013. |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Schedule A BI 847325 9 mg (A2) | Schedule A BI 847325 9 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 1 | 3 | 3 | 3 |
| EG002 | Schedule A BI 847325 13 mg (A3) | Schedule A BI 847325 13 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 0 | 3 | 3 | 3 |
| EG003 | Schedule A BI 847325 19 mg (A4) | Schedule A BI 847325 19 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 1 | 3 | 2 | 3 |
| EG004 | Schedule A BI 847325 26 mg (A5) | Schedule A BI 847325 26 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 5 | 7 | 7 | 7 |
| EG005 | Schedule A BI 847325 33 mg (A6) | Schedule A BI 847325 33 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 3 | 7 | 7 | 7 |
| EG006 | Schedule A BI 847325 46 mg (A7) | Schedule A BI 847325 46 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 1 | 3 | 3 | 3 |
| EG007 | Schedule A BI 847325 63 mg (A8) | Schedule A BI 847325 63 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 0 | 3 | 3 | 3 |
| EG008 | Schedule A BI 847325 86 mg (A9) | Schedule A BI 847325 86 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 4 | 5 | 5 | 5 |
| EG009 | Schedule A BI 847325 120 mg (A10) | Schedule A BI 847325 120 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 2 | 6 | 6 | 6 |
| EG010 | Schedule A BI 847325 160 mg (A11) | Schedule A BI 847325 160 mg/day group. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 4 | 4 | 4 | 4 |
| EG011 | Schedule A Total (Total A) | All patients with schedule A. Schedule A: 2 weeks on treatment, 1 week off treatment, repeated every 3 weeks. | 22 | 47 | 46 | 47 |
| EG012 | Schedule B BI 847325 6 mg (B1) | Schedule B BI 847325 6 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 1 | 1 | 1 | 1 |
| EG013 | Schedule B BI 847325 12 mg (B2) | Schedule B BI 847325 12 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 0 | 1 | 1 | 1 |
| EG014 | Schedule B BI 847325 23 mg (B3) | Schedule B BI 847325 23 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 0 | 1 | 1 | 1 |
| EG015 | Schedule B BI 847325 46 mg (B4) | Schedule B BI 847325 46 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 0 | 1 | 1 | 1 |
| EG016 | Schedule B BI 847325 90 mg (B5) | Schedule B BI 847325 90 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 1 | 3 | 3 | 3 |
| EG017 | Schedule B BI 847325 180 mg (B6) | Schedule B BI 847325 180 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 2 | 3 | 3 | 3 |
| EG018 | Schedule B BI 847325 130 mg (B7) | Schedule B BI 847325 130 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 4 | 6 | 6 | 6 |
| EG019 | Schedule B BI 847325 150 mg (B8) | Schedule B BI 847325 150 mg/day group. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. BI 847325 tablet(s) administered once daily in the morning 1 hour before breakfast and taken with at least 250 mL of water. | 1 | 6 | 6 | 6 |
| EG020 | Schedule B Total (Total B) | Schedule B total treated patients. Schedule B: 5 days on treatment, 2 days off treatment, repeated every week, in 3-week cycles. | 9 | 22 | 22 | 22 |
| EG021 | Total Patients | Schedule A and B total patients. | 31 | 69 | 68 | 69 |
| Cardiac tamponade | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Euthanasia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Electrocardiogram ST segment elevation | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Troponin I increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Endocrine disorder | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Radiation alopecia | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Troponin T increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypovitaminosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vascular compression | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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.
| partial response |
|
| stable disease |
|
| progressive disease |
|
| not evaluable |
|
| Objective response: Yes |
|
| Disease control: Yes |
|