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

NCT ID: NCT01938846

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-05
• Study Completion Date: 2017-06-22

Brief 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

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 860585

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

Group Type: EXPERIMENTAL

BI 860585

Intervention Type: DRUG

BI 860585 multiple dose escalation, once daily

BI 860585 + paclitaxel

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

Group Type: EXPERIMENTAL

BI 860585

Intervention Type: DRUG

BI 860585 multiple dose escalation, once daily

paclitaxel

Intervention Type: DRUG

paclitaxel once weekly

BI 860585 + exemestane

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

Group Type: EXPERIMENTAL

exemestane

Intervention Type: DRUG

exemestane once daily

BI 860585

Intervention Type: DRUG

BI 860585 multiple dose escalation, once daily

Interventions

BI 860585

BI 860585 multiple dose escalation, once daily

Intervention Type: DRUG

exemestane

exemestane once daily

Intervention Type: DRUG

BI 860585

BI 860585 multiple dose escalation, once daily

Intervention Type: DRUG

BI 860585

BI 860585 multiple dose escalation, once daily

Intervention Type: DRUG

paclitaxel

paclitaxel once weekly

Intervention Type: DRUG

Eligibility Criteria

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.

• 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;

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Brussels - UNIV Saint-Luc

Brussels, , Belgium

UNIV UZ Gent

Ghent, , Belgium

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Azienda Ospedaliera di Parma

Parma, , Italy

Countries

Belgium; Italy

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2013-000765-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1325.1

Identifier Type: -

Identifier Source: org_study_id