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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01938846
Other study ID # 1325.1
Secondary ID 2013-000765-36
Status Completed
Phase Phase 1
First received
Last updated
Start date September 5, 2013
Est. completion date June 22, 2017

Study information

Verified date June 2018
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 22, 2017
Est. primary completion date July 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion criteria:

- Patients with histologically or cytologically confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic solid tumours, which has shown to be progressive;

- Patients who have received previous standard of care therapy for their disease and have progressed;

- 18 years or older;

- Life expectancy >= 3 months;

- Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation;

- Eastern Cooperative Oncology Group (ECOG), performance score 0-2.

Additional inclusion criteria for the combination arms:

- Patients must have confirmed progressive disease within the last 6 months, (in case of measurable disease, progression should be confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1;

- Patients carrying a tumour for whom treatment with either exemestane or paclitaxel would be considered appropriate by the investigator;

Additional inclusion criteria for expansion part:

- Patients must have measurable progressive disease within the last 6 months documented/proven according to RECIST criteria version 1.1.

- Patients entering the expansion cohorts must also have:

- Arm A: any advanced/metastatic solid tumour suitable for biopsy and must have provided informed consent for biopsy and biomarker analysis.

- Arm B: any cytologically or histologically confirmed ER+ (estrogen receptor positive) advanced/metastatic solid tumours for which treatment with exemestane would be considered appropriate by the investigator.

- Arm C: any advanced/metastatic solid tumour for which treatment with paclitaxel would be considered appropriate by the investigator.

Exclusion criteria:

- Serious concomitant non-oncological disease/illness considered by the investigator to be incompatible with the protocol;

- Patients with untreated or symptomatic brain metastases;

- Second malignancies requiring active therapy;

- Clinical Congestive Heart Failure (CHF) Grade III-IV;

- Myocardial infarction within the last 6 months prior to inclusion, or symptomatic coronary artery disease;

- Adequate bone marrow, liver and renal function;

- Patients with known HIV/hepatitis/active infectious disease considered by the investigator to be incompatible with the protocol;

- Patients unable to take oral medication;

- Chronic diarrhoea or other gastrointestinal disorders;

- Treatment with anti-cancer-therapies: cytotoxic or standard chemotherapy, immunotherapy, radiotherapy, biological therapies, molecular targeted or other investigational drugs, within four weeks of the first treatment with the study medication (or within one week for non-cytotoxic drugs);

- Recovery from previous surgery and anticancer medical treatments;

- Hypersensitivity to combination drugs or excipients;

- Patients with a history of uncontrolled diabetes mellitus.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BI 860585
BI 860585 multiple dose escalation, once daily
exemestane
exemestane once daily
BI 860585
BI 860585 multiple dose escalation, once daily
BI 860585
BI 860585 multiple dose escalation, once daily
paclitaxel
paclitaxel once weekly

Locations

Country Name City State
Belgium Brussels - UNIV Saint-Luc Bruxelles
Belgium UNIV UZ Gent Gent
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Italy Azienda Ospedaliera di Parma Parma

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
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. 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. 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) 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) 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. 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. 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 (AUC0-8) AUC0-8, 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.
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 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 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 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 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 (AUCt,ss) AUCt,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.
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. 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. 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. Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.
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