Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Exemestane

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Multiple ascending doses of BI 860585 administered continuously in a 28-day cycle, including food interaction cohorts

Multiple ascending doses of BI 860585 in combination with fixed dose paclitaxel

Multiple ascending doses of BI 860585 in combination with fixed dose exemestane

BI 860585 multiple dose escalation, once daily

BI 860585

exemestane

paclitaxel

Boehringer Ingelheim

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

BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

An Open Label Phase I Dose Finding Study of BI 860585 Administered Orally in a Continuous Dosing Schedule as Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumours

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.

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.

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)

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)

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.

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.

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

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

t ½, half-life of BI 860585 in plasma over a dosing interval after single administration of BI 860585

Cmax, maximum measured concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585

Tmax, Time to maximum concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585

AUCτ,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.

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.

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.

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.

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.

Continuous daily oral dose of 5 milligram/day (starting dose) over 28-day treatment courses of BI 860585 Monotherapy

5 mg BI 860585

Continuous daily oral dose of 10 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

10 mg BI 860585

Continuous daily oral dose of 20 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

20 mg BI 860585

Continuous daily oral dose of 40 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

40 mg BI 860585

Continuous daily oral dose of 80 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

80 mg BI 860585

Continuous daily oral dose of 120 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

120 mg BI 860585

Continuous daily oral dose of 160 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

160 mg BI 860585

Continuous daily oral dose of 220 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

220 mg BI 860585

Continuous daily oral dose of 300 milligram/day over 28-days treatment courses of BI 860585 Monotherapy

300 mg BI 860585

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

40 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

80 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

120 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

160 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

220 mg BI 860585+25 mg Exemestane

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

80 mg BI 860585+60 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

80 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

120 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

160 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

220 mg BI 860585+80 mg/m^2 Paclitaxel

Patients were administered with BI 860585 daily oral dose of 5 milligram starting dose) over 28-day treatment courses

BI 860585 Monotherapy

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

BI 860585 + Exemestane

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

BI 860585 + Paclitaxel

Total

Age at the time of signing informed consent form is presented.

Age, Continuous

Number of subjects is categorized as Male or Female.

Sex: Female, Male

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).

The trial was discontinued at the end of the dose-escalation phase for each treatment arm, before starting the expansion phase.

Boehringer Ingelheim, Call Centre

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.

The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm

The Maximum Tolerated Dose (MTD) for Each Treatment Arm

Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel).

Objective Response Rate (Complete Response or Partial Response as Per the Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1)

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)

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)).

Duration of Clinical Benefit

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)).

Duration of Objective Response

Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 40 mg BI 860585

Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 80 mg BI 860585

Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 120 mg BI 860585

Continuous daily oral dose of 25 mg/day standard fixed dose of exemestane over 28-day treatment courses combination with 160 mg BI 860585

Continuous daily oral dose of 160 mg BI 860585 in combination with once weekly iv infusion of 80 mg/m\^2 paclitaxel

160 mg BI 860585+80 mg/m^2 Paclita

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.

Spots Global Cancer Trial Database for BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial