Clinical trial NCT02999672 (phase 2, status: completed)
Conditions: bladder cancer, pancreas cancer, cholangiocellular carcinoma
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4, D13.6, C25.4, C25.9, D13.7, C25.0, C25.1, C25.2, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: trastuzumab emtansine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically centrally confirmed HER2-positive (immunohistochemistry [IHC]3+ in
             greater than or equal to [>/=] 30 percent [%] of tumor cells): locally advanced
             (unresectable and not treatable with curative intent), or metastatic UBC or locally
             advanced (unresectable and not treatable with curative intent) or metastatic
             pancreatic cancer/cholangiocarcinoma

          -  There must be no standard treatment options available for participants with the above
             HER2 overexpressing tumors and they must have undergone at least one prior
             platinum-based treatment for locally advanced (unresectable and not treatable with
             curative intent) or metastatic tumor (Note: for pancreatic cancer/cholangiocarcinoma,
             prior treatments are not required to be platinum-based.)

          -  Participant's lesion should be measurable according to RECIST V1.1 on diagnostic
             computed tomography (CT) scan/magnetic resonance imaging (MRI); Target lesion(s)
             should not have been previously irradiated

          -  At least one formalin-fixed paraffin-embedded (FFPE) biopsy of the primary tumor
             and/or from a metastatic site is required

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2

          -  No significant cardiac history and a current left ventricular ejection fraction (LVEF)
             >/=50%

          -  Adequate organ function

          -  Life expectancy of at least 12 weeks

        Exclusion Criteria:

          -  Participants with previous exposure to HER2-targeted therapies in any setting

          -  Participants showing histologically confirmed focal HER2-expression, that is, less
             than (<) 30% of positively stained tumor cells

          -  Participants with brain metastasis as the sole site of metastatic disease and/or are
             symptomatic or require therapy to control symptoms

          -  Current uncontrolled hypertension (systolic greater than [>] 150 millimeters of
             mercury [mmHg] and/or diastolic >100 mmHg)

          -  Current unstable angina pectoris

          -  History of symptomatic congestive heart failure (CHF) of any New York Heart
             Association (NYHA) criteria or ventricular arrhythmia that requires treatment

          -  History of myocardial infarction within the last 6 months

          -  Peripheral neuropathy, Grade >/=3

          -  Current dyspnea at rest due to complications of advanced malignancy, or other diseases
             that require continuous oxygen therapy

          -  Current severe, uncontrolled systemic disease

          -  History of other malignancy within the last 5 years

          -  Concurrent, serious, uncontrolled infections or current known infection with human
             immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C

          -  Known prior severe hypersensitivity to trastuzumab and trastuzumab emtansine or the
             excipients of the investigational medicinal product (IMP)

          -  Clinically significant bleeding within 30 days before enrollment

          -  Major surgical procedure or significant traumatic injury within 28 days prior to
             randomization or anticipation of the need for major surgery during the course of study
             treatment

          -  Concurrent participation in any other therapeutic clinical trial