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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000765-36 | EudraCT Number |
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The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI 860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs, patients are entered sequentially into escalating dose cohorts. Secondary objectives are objective response and disease control according to RECIST criteria version 1.1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 860585 | Experimental | Multiple ascending doses of BI 860585 administered continuously in a 28-day cycle, including food interaction cohorts |
|
| BI 860585 + paclitaxel | Experimental | Multiple ascending doses of BI 860585 in combination with fixed dose paclitaxel |
|
| BI 860585 + exemestane | Experimental | Multiple ascending doses of BI 860585 in combination with fixed dose exemestane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 860585 | Drug | BI 860585 multiple dose escalation, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm | The number of patients with Dose-Limiting Toxicities (DLTs) in the first course of each treatment arm to identify the Maximum Tolerated Dose (MTD) for BI 860585 monotherapy and BI 860585 in combination with exemestane of paclitaxel. | 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle)) |
| The Maximum Tolerated Dose (MTD) for Each Treatment Arm | The Maximum Tolerated Dose (MTD) for each treatment arm was the dose that was 1 dose cohort below that at which ≥2 of 6 patients had experienced DLT. i.e., the MTD was the highest dose studied for which the DLT incidence was no more than 17% (i.e. 1 of 6 patients) during the first treatment course. | 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle)) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Complete Response or Partial Response as Per the Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1) | As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for objective response rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT) |
Not provided
Inclusion criteria:
Additional inclusion criteria for the combination arms:
Additional inclusion criteria for expansion part:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels - UNIV Saint-Luc | Brussels | 1200 | Belgium | |||
| UNIV UZ Gent |
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
An open-label, Phase I, dose-finding study of BI 860585, a total of 90 patients received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 860585 Monotherapy | Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses |
| FG001 | BI 860585 + Exemestane | Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2016 | Jun 15, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
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| exemestane |
| Drug |
exemestane once daily |
|
| BI 860585 | Drug | BI 860585 multiple dose escalation, once daily |
|
| BI 860585 | Drug | BI 860585 multiple dose escalation, once daily |
|
| paclitaxel | Drug | paclitaxel once weekly |
|
| From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days |
| Disease Control Rate/Clinical Benefit Rate (Complete Response, Partial Response or Stable Disease as Per Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1) | As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for disease control rate/clinical benefit rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT) | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy. |
| Duration of Clinical Benefit | Duration of clinical benefit (Disease control) was defined as the time between first treatment administration until the earliest of disease progression or death, for patients with disease control. | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days |
| Duration of Objective Response | Duration of objective response was defined as the time from first objective response until the earliest of progression or death, for patients with objective response. | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days |
| Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to Infinity (AUC0-∞) | AUC0-∞, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to infinity after single administration of BI 860585 | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to 24 Hours (AUC0-24) | AUC0-24, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to 24 hours after single administration of BI 860585 | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| Half Life of BI 860585 (t1/2) | t ½, half-life of BI 860585 in plasma over a dosing interval after single administration of BI 860585 | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| Maximum Measured Concentration of BI 860585 (Cmax) | Cmax, maximum measured concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585 | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| Time to Maximum Concentration of BI 860585 (Tmax) | Tmax, Time to maximum concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585 | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| Area Under the Concentration-time Curve of BI 860585 in Plasma Over a Dosing Interval at Steady State (AUCÏ„,ss) | AUCÏ„,ss, area under the concentration-time curve of BI 860585 in plasma over the dosing interval at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| Half Life of BI 860585 at Steady State (t1/2,ss) | t1/2,ss, half-life of BI 860585 in plasma at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| Time to Maximum Concentration of BI 860585 at Steady State (Tmax,ss) | tmax,ss, Time to maximum concentration of BI 860585 at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| Maximum Measured Concentration of BI 860585 in Plasma at Steady State (Cmax,ss) | Cmax,ss, maximum measured concentration at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| Ghent |
| 9000 |
| Belgium |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Azienda Ospedaliera di Parma | Parma | 43126 | Italy |
| FG002 | BI 860585 + Paclitaxel | Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses |
|
| COMPLETED | Not discontinued from last trial medication |
|
| NOT COMPLETED |
|
|
Treated set (TS): The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 860585 Monotherapy | Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses |
| BG001 | BI 860585 + Exemestane | Patients were administered with daily oral dose of BI 860585 in combination with 25 milligram/day standard fixed dose of Exemestane over 28-day treatment courses |
| BG002 | BI 860585 + Paclitaxel | Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of signing informed consent form is presented. | TS | Mean | Standard Deviation | Years |
| |||||||||||||
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | TS | Count of Participants | Participants |
|
| 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 | The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm | The number of patients with Dose-Limiting Toxicities (DLTs) in the first course of each treatment arm to identify the Maximum Tolerated Dose (MTD) for BI 860585 monotherapy and BI 860585 in combination with exemestane of paclitaxel. | Treated and Evaluable Set: The treated and evaluable set includes all patients who were administered at least one dose of study medication and who are evaluable with respect to DLT in the MTD evaluation period. | Posted | Count of Participants | Participants | 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle)) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | The Maximum Tolerated Dose (MTD) for Each Treatment Arm | The Maximum Tolerated Dose (MTD) for each treatment arm was the dose that was 1 dose cohort below that at which ≥2 of 6 patients had experienced DLT. i.e., the MTD was the highest dose studied for which the DLT incidence was no more than 17% (i.e. 1 of 6 patients) during the first treatment course. | Treated and Evaluable Set: The treated and evaluable set includes all patients who were administered at least one dose of study medication and who are evaluable with respect to DLT in the MTD evaluation period. | Posted | Number | Milligram (mg) | 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle)) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (Complete Response or Partial Response as Per the Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1) | As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for objective response rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT) | Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel). | Posted | Count of Participants | Participants | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate/Clinical Benefit Rate (Complete Response, Partial Response or Stable Disease as Per Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1) | As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for disease control rate/clinical benefit rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT) | Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel). | Posted | Count of Participants | Participants | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Clinical Benefit | Duration of clinical benefit (Disease control) was defined as the time between first treatment administration until the earliest of disease progression or death, for patients with disease control. | Patients with disease control from the treated set (Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel)). | Posted | Mean | Standard Deviation | Months | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response | Duration of objective response was defined as the time from first objective response until the earliest of progression or death, for patients with objective response. | Patients with objective response from the treated set (Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel)). | Posted | Mean | Standard Deviation | Months | From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to Infinity (AUC0-∞) | AUC0-∞, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to infinity after single administration of BI 860585 | Pharmacokinetic Analysis Set (PKS): This patient set includes all evaluable patients in the treated set (TS) which provide at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol*hour/ Litre [nmol*h/L] | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to 24 Hours (AUC0-24) | AUC0-24, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to 24 hours after single administration of BI 860585 | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol*hour/ Litre [nmol*h/L] | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| |||||||||||||||||||||||||||||||||
| Secondary | Half Life of BI 860585 (t1/2) | t ½, half-life of BI 860585 in plasma over a dosing interval after single administration of BI 860585 | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour (h) | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration of BI 860585 (Cmax) | Cmax, maximum measured concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585 | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Litre [nmol/L] | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration of BI 860585 (Tmax) | Tmax, Time to maximum concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585 | PKS | Posted | Median | Full Range | Hour (h) | Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585. |
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve of BI 860585 in Plasma Over a Dosing Interval at Steady State (AUCÏ„,ss) | AUCÏ„,ss, area under the concentration-time curve of BI 860585 in plasma over the dosing interval at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol*hour/ Litre [nmol*h/L] | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| |||||||||||||||||||||||||||||||||
| Secondary | Half Life of BI 860585 at Steady State (t1/2,ss) | t1/2,ss, half-life of BI 860585 in plasma at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour (h) | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration of BI 860585 at Steady State (Tmax,ss) | tmax,ss, Time to maximum concentration of BI 860585 at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | PKS | Posted | Median | Full Range | Hour (h) | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration of BI 860585 in Plasma at Steady State (Cmax,ss) | Cmax,ss, maximum measured concentration at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol/ Litre [nmol/L] | Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration. |
|
From first drug administration until 28 days after last drug administration; up to 209 weeks
The treated set (includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane, or paclitaxel)) was used for safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5 mg BI 860585 | Continuous daily oral dose of 5 milligram/day (starting dose) over 28-day treatment courses of BI 860585 Monotherapy | 1 | 3 | 2 | 3 | 3 | 3 |
| EG001 | 10 mg BI 860585 | Continuous daily oral dose of 10 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 1 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 20 mg BI 860585 | Continuous daily oral dose of 20 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 1 | 3 | 2 | 3 | 3 | 3 |
| EG003 | 40 mg BI 860585 | Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 0 | 3 | 1 | 3 | 3 | 3 |
| EG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 1 | 7 | 4 | 7 | 7 | 7 |
| EG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 1 | 7 | 4 | 7 | 7 | 7 |
| EG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 0 | 9 | 4 | 9 | 9 | 9 |
| EG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy | 0 | 3 | 2 | 3 | 3 | 3 |
| EG009 | 40 mg BI 860585+25 mg Exemestane | Patients were administered with daily oral dose of 40 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses | 0 | 3 | 0 | 3 | 3 | 3 |
| EG010 | 80 mg BI 860585+25 mg Exemestane | Patients were administered with daily oral dose of 80 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses | 3 | 4 | 4 | 4 | 4 | 4 |
| EG011 | 120 mg BI 860585+25 mg Exemestane | Patients were administered with daily oral dose of 120 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses | 1 | 7 | 3 | 7 | 7 | 7 |
| EG012 | 160 mg BI 860585+25 mg Exemestane | Patients were administered with daily oral dose of 160 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses | 0 | 8 | 2 | 8 | 8 | 8 |
| EG013 | 220 mg BI 860585+25 mg Exemestane | Patients were administered with daily oral dose of 220 mg BI 860585 in combination with 25 mg exemestane standard fixed dose over 28-day treatment courses | 0 | 3 | 1 | 3 | 3 | 3 |
| EG014 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses | 0 | 3 | 2 | 3 | 3 | 3 |
| EG015 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses | 0 | 4 | 3 | 4 | 4 | 4 |
| EG016 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses | 0 | 7 | 3 | 7 | 7 | 7 |
| EG017 | 160 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 160 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses | 0 | 7 | 4 | 7 | 7 | 7 |
| EG018 | 220 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 220 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Perihepatic abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral oesophagitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Anaesthetic complication pulmonary | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Aorto-duodenal fistula | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Maculopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral oesophagitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperlipasaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Head titubation | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Postural tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
The trial was discontinued at the end of the dose-escalation phase for each treatment arm, before starting the expansion phase.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 13, 2015 | Jun 15, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C056516 | exemestane |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
|
|
Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses |
|
|
| OG002 | BI 860585 + Paclitaxel | Patients were administered with BI 860585 in combination with Paclitaxel weekly intravenous infusion of 60 milligram/meter^2 for the first dose level/treatment cohort and 80 milligram/meter^2 (the standard combination dose) for subsequent dose levels/treatment cohorts over 28-day treatment courses |
|
|
|
|
|
|
| OG003 | 40 mg BI 860585 | Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|
| OG004 | 80 mg BI 860585 | Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG005 | 120 mg BI 860585 | Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG006 | 160 mg BI 860585 | Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG007 | 220 mg BI 860585 | Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG008 | 300 mg BI 860585 | Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy |
| OG009 | 40 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585 |
| OG010 | 80 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585 |
| OG011 | 120 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585 |
| OG012 | 160 mg BI 860585+25 mg Exemestane | Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585 |
| OG013 | 80 mg BI 860585+60 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 60 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG014 | 80 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 80 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG015 | 120 mg BI 860585+80 mg/m^2 Paclitaxel | Patients were administered with 120 mg BI 860585 in combination with weekly intravenous infusion of 80 mg/m^2 the standard combination dose of paclitaxel for the first dose level/treatment for subsequent dose levels/treatment cohorts over 28-day treatment courses |
| OG016 | 160 mg BI 860585+80 mg/m^2 Paclita | Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m^2 paclitaxel |
|
|