BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
Condition: Neoplasms
Intervention: BI 860585; exemestane; BI 860585; BI 860585; paclitaxel
Intervention description: BI 860585 multiple dose escalation, once daily; exemestane once daily; BI 860585 multiple dose escalation, once daily; BI 860585 multiple dose escalation, once daily; paclitaxel once weekly
Intervention MeSH terms: Paclitaxel; Exemestane
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

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
    

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.

        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.