NeoplasmsPhase 1NCT01938846
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
A Phase 1 study testing BI 860585, exemestane and paclitaxel in people with Neoplasms, run by Boehringer Ingelheim at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- BI 860585, exemestane and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 5 Sep 2013to 22 Jun 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium2 sites
Brussels - UNIV Saint-Luc
Brussels, 1200
UNIV UZ Gent
Ghent, 9000
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Azienda Ospedaliera di Parma
Parma, 43126
About this study
Official title: 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 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
- Conditions
- Neoplasms
- Being tested
- BI 860585, exemestane, paclitaxel
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 860585Drug
BI 860585 multiple dose escalation, once daily
exemestaneDrug
exemestane once daily
BI 860585Drug
BI 860585 multiple dose escalation, once daily
BI 860585Drug
BI 860585 multiple dose escalation, once daily
paclitaxelDrug
paclitaxel once weekly
| Study group | Role | What they receive |
|---|---|---|
| BI 860585 | Experimental | Multiple ascending doses of BI 860585 administered continuously in a 28-day cycle, including food interaction cohorts Receives: Drug: BI 860585 |
| BI 860585 + paclitaxel | Experimental | Multiple ascending doses of BI 860585 in combination with fixed dose paclitaxel Receives: Drug: BI 860585; Drug: paclitaxel |
| BI 860585 + exemestane | Experimental | Multiple ascending doses of BI 860585 in combination with fixed dose exemestane Receives: Drug: exemestane; Drug: BI 860585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))
Secondary outcomes (13)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (AUCτ,ss)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study start5 Sep 2013
- Primary completion30 Jul 2016
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938846
- Sponsor's protocol ID
- 1325.1
- Other IDs
- 2013-000765-36
- Status last verified
- Jun 2018
- First submitted
- 5 Sep 2013
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01938846
- Acronym / sponsor ID
- 1325.1
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2013 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 4 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 860585 | Experimental | Drug: BI 860585Multiple ascending doses of BI 860585 administered continuously in a 28-day cycle, including food interaction cohorts |
| BI 860585 + paclitaxel | Experimental | Drug: BI 860585, Drug: paclitaxelMultiple ascending doses of BI 860585 in combination with fixed dose paclitaxel |
| BI 860585 + exemestane | Experimental | Drug: exemestane, Drug: BI 860585Multiple ascending doses of BI 860585 in combination with fixed dose exemestane |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 860585BI 860585 multiple dose escalation, once daily | Drug | BI 860585 + paclitaxel |
| exemestaneexemestane once daily | Drug | BI 860585 + exemestane |
| BI 860585BI 860585 multiple dose escalation, once daily | Drug | BI 860585 |
| BI 860585BI 860585 multiple dose escalation, once daily | Drug | BI 860585 + exemestane |
| paclitaxelpaclitaxel once weekly | Drug | BI 860585 + paclitaxel |
Primary outcome
The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm
Time frame: 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))
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
Time frame: 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))
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.
13 secondary outcomes
Objective Response Rate (Complete Response or Partial Response as Per the Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 (AUCτ,ss)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 860585, exemestane and paclitaxel in people with Neoplasms, run by Boehringer Ingelheim at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm (time frame: 28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.