Status:
COMPLETED
EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Colorectal and Ovarian Cancer Patients With Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00848510
Start Date
February 1 2009
End Date
November 1 2013
Last Update
December 14 2015
Active Locations (1)
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1
Christie Hospital
Manchester, United Kingdom