EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases

NCT ID: NCT00848510

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-11-30

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 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.

Conditions

Colorectal and Ovarian Cancer Patients With Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMD 525797

Group Type: EXPERIMENTAL

EMD 525797

Intervention Type: BIOLOGICAL

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.

Interventions

EMD 525797

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.

Intervention Type: BIOLOGICAL

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)

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

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Christie Hospital

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2008-001820-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EMR 62242-003

Identifier Type: -

Identifier Source: org_study_id