EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases
Condition: Colorectal and Ovarian Cancer Patients With Liver Metastases
MeSH terms: Neoplasm Metastasis; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Liver Neoplasms
Intervention: EMD 525797
Intervention description: Abituzumab will be administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) to 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) that will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) during initial 6 Weeks, subjects will be allowed to continue treatment at the start of Week 7 at the given dose (250 mg or 500 mg or 1000 mg or 1500 mg) every second week until intolerance to treatment, withdrawal of consent, or the subject is no longer benefiting from treatment in the opinion of the Investigator.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is intended to test an experimental drug called EMD 525797 (Abituzumab). This drug
      is not yet approved for sale and has only been tested in a small number of people to date
      (prior to this study starting another research study was carried out involving 37 healthy
      volunteers receiving the study drug). Until more is known about this study drug, it can only
      be used in research studies.

      This research study is planned to answer important questions about how the study drug is
      tolerated and how it may work in subjects with ovarian and colorectal cancer which has spread
      to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing
      the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed written informed consent

          -  Male or female subjects, aged at least 18 years

          -  Subjects with liver metastases (3 to 10 centimeter [cm] diameter) from colorectal and
             ovarian cancers

          -  Failure of standard cancer therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study entry
             and an estimated life expectancy of at least 3 months

          -  Adequate haematological function, defined by absolute neutrophil count (ANC) greater
             than or equal to (>=) 1.5 x 10^9 per liter (/L), platelet count >= 100 x 10^9 / L, and
             haemoglobin concentration >= 9 gram per deciliter (g/dL)

          -  As subjects with documented liver metastases are treated in this trial, liver function
             test values are accepted as followed: up to the upper limit of Grade 2 as defined by
             National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
             Version 3.0. This includes total bilirubin level less than or equal to (=<) 3 times
             the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine
             aminotransferase (ALT) levels =<5 x ULN

          -  Adequate renal function defined by serum creatinine =<1.5 x ULN or a creatinine
             clearance of >=50 milliliter per minute (mL/min) calculated by Cockcroft-Gault

          -  Effective contraception (example: double barrier method) for both male and female
             subjects if the risk of conception exists. These subjects must be willing to avoid
             pregnancy during the study (screening to end of study [EOS]) as well as for at least 3
             months after the last dosing.

        Exclusion Criteria:

          -  Any systemic cancer treatment within 30 days before treatment with EMD 525797

          -  Thrombolytics or oral or parenteral anticoagulants (except to maintain patency of
             preexisting, permanent indwelling intravenous catheters) within 10 days prior to study
             start and during treatment

          -  Radiotherapy, chemotherapy, surgery, or any investigational drug in the 30 days before
             the start of treatment in this study, and/or diagnostic biopsies within 2 weeks before
             the start of treatment in this study

          -  Previous treatment with anti-integrin therapy or anti angiogenic therapy within the
             last 6 months

          -  Confirmed or clinically suspected brain metastases

          -  Known hypersensitivity reactions to the study medication

          -  History of allergic reactions to other monoclonal antibody (mAb) therapy

          -  Uncontrolled hypertension (systolic blood pressure greater than (>) 180 millimeter of
             mercury (mmHg), diastolic >100 mmHg)

          -  Current history of chronic daily aspirin therapy (doses of =< 150 mg is permitted),
             bleeding disorders, and/or history of thromboembolic events

          -  Severe peripheral vascular disease or ulceration

          -  Unstable angina pectoris, or myocardial infarction within 6 months before start of
             study treatment, clinical significant abnormal electrocardiogram (ECG) at screening;

          -  In women of childbearing potential, pregnancy (absence to be confirmed by beta human
             chorionic gonadotropin [β HCG] test, unless a subject has previously undergone
             hysterectomy or bilateral ovariectomy), or lactation period

          -  Known alcohol or drug abuse

          -  Participation in another clinical trial within the past 30 days before start of study
             treatment

          -  All other significant diseases which, in the opinion of the principal investigator
             (PI), might impair the subject's tolerance of study treatment

          -  Dementia, altered mental status, or any psychiatric condition that would prohibit the
             understanding or rendering of informed consent

          -  Legal incapacity or limited legal capacity (not applicable only in rare cases)

          -  Known human immuno deficiency (HIV) infection and/or active hepatitis B or C virus
             infections

          -  Ongoing uncontrolled infections

          -  Contraindications to magnetic resonance imaging (MRI)