Phase 1 N=41 Treatment

EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases

Colorectal and Ovarian Cancer Patients With Liver Metastases

Bottom Line

View on ClinicalTrials.gov: NCT00848510 ↗

Enrolled (actual)

Serious AEs

58.5%

Results posted

Dec 2015

Primary outcome: Primary: Number of Subjects With Dose Limiting Toxicities (DLTs) — 1; 1; 0; 2 Subjects

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: EMD 525797 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Dose Limiting Toxicities (DLTs)	1; 1; 0; 2	—
PRIMARY Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls	0.233; 0.214; 0.221; 0.141; 0.253; 0.177	—
PRIMARY Blood Plasma Volume and Extravascular/Extracellular Volume	0.024; 0.014; 0.020; 0.022; 0.024; 0.013	—
PRIMARY Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60)	21.900; 20.844; 22.752; 16.602; 21.155; 17.670	—
PRIMARY Whole Tumor Volume and Enhancing Tumor Volume	180310.380; 83921.304; 58662.341; 58665.247; 195939.314; 73940.030	—
SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death	10; 13; 8; 10; 5; 7	—
SECONDARY Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score	4; 8; 4; 5	—
SECONDARY Number of Subjects With Positive Binding Abituzumab Antibodies	0; 1; 0; 0; 1; 0	—
SECONDARY Progression-Free Survival (PFS) Time	1.22; 0.77; 1.40; 1.08	—

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 (= =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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00848510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.