A Study of EMD525797 in Solid Tumor Patients in Japan

NCT ID: NCT01327313

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-10-31

Brief Summary

The primary objectives are to assess the safety and tolerability of single and repeated doses of EMD525797, and characterize Pharmacokinetics (PK). The secondary objectives are to investigate the immunogenicity and Progressive disease (PD), and to assess the anti-tumor activity of EMD525797.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMD525797 250 milligram (mg)

Group Type: EXPERIMENTAL

EMD525797

Intervention Type: BIOLOGICAL

Subjects will receive 250 milligram (mg) of EMD525797 intravenously every 2 weeks, until progressive disease (PD), unacceptable toxicity or withdrawal of consent.

EMD525797 500 mg

Group Type: EXPERIMENTAL

EMD525797

Intervention Type: BIOLOGICAL

Subjects will receive 500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.

EMD525797 1000 mg

Group Type: EXPERIMENTAL

EMD525797

Intervention Type: BIOLOGICAL

Subjects will receive 1000 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.

EMD525797 1500 mg

Group Type: EXPERIMENTAL

EMD525797

Intervention Type: BIOLOGICAL

Subjects will receive 1500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity, or withdrawal of consent.

Interventions

EMD525797

Subjects will receive 250 milligram (mg) of EMD525797 intravenously every 2 weeks, until progressive disease (PD), unacceptable toxicity or withdrawal of consent.

Intervention Type: BIOLOGICAL

EMD525797

Subjects will receive 500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.

Intervention Type: BIOLOGICAL

EMD525797

Subjects will receive 1000 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.

Intervention Type: BIOLOGICAL

EMD525797

Subjects will receive 1500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity, or withdrawal of consent.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to (>=) 20 years
• Histologically or cytologically proven advanced or metastatic solid tumor
• Evidence of progressive disease after standard chemotherapy or no standard chemotherapy
• Confirmation of availability of formalin-fixed paraffin-embedded (FFPE) tumor block(s) or tissue sections
• Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 complete tumor assessment to be performed within the 30 days prior to the first EMD525797 administration
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Estimated life expectancy of at least 3 months
• Absolute Neutrophil Count (ANC) >= 1.5 x 10^9 per liter (/Liter)
• Platelets >= 100 x 10^9/Liter
• Haemoglobin >= 9.0 gram per deciliter (g/dL) (without transfusions)
• Total bilirubin less than or equal to (<=) 1.5 x upper limit of normal (ULN)
• Aspartate transaminase (AST), alanine transaminase (ALT) less than or equal to (<=) 3 x ULN
• In subjects with hepatic metastasis, total bilirubin <= 3 x ULN, AST and ALT <= 5 x ULN
• Prothrombin time (PT), prothrombin time/international normalized ratio (PT/INR), and activated partial thromboplastin time (APTT) within normal limits
• Creatinine clearance >= 50 milliliter per minute (mL/min)

Exclusion Criteria

• Previous treatment with anti-integrin therapy
• Radiotherapy to bone lesions, systemic surgery, orthopedic surgery (all within the 4 week prior to treatment with EMD525797), clinically significant unhealed wound, or unrecovered bone fracture
• Chronic doses of oral steroids, defined as >= 10 milligram of prednisone equivalents per day
• Confirmed or clinically suspected brain or leptomeningeal metastases
• Known hypersensitivity to EMD525797 or its excipients
• History of allergic reactions to other monoclonal antibody therapy
• Antibody treatment within the past 8 weeks or chemotherapy within the 4 weeks prior to treatment with EMD525797
• Uncontrolled diabetes
• Uncontrolled hypertension defined as systolic blood pressure >= 160 millimeter of mercury (mmHg) and/or diastolic blood pressure >= 100 millimeter of mercury (mmHg) under resting conditions
• Autoimmune diseases
• Current history of chronic daily acetylsalicylic acid (ASS) therapy (ASS at doses <=100 mg is permitted)
• Bleeding disorders;
• History of thromboembolic events (history of superficial thrombophlebitis is not an exclusion
• Anticoagulants within the past 10 days prior to the first treatment and during treatment period
• Severe peripheral vascular disease or ulceration
• Unstable angina pectoris, or myocardial infarction or other severe heart diseases within the past 6 months before treatment with EMD 525797
• Clinical significant abnormal ECG at screening
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
• Known HIV infection, active or chronic carrier of hepatitis B virus (HBV antigen positive or HBV DNA positive) or hepatitis C virus (HCV antibody positive)

• Minimum Eligible Age: 20 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 Serono Co., Ltd., Japan

Locations

For Recruiting

Locations in, , Japan

Countries

Japan

Other Identifiers

EMR200017-007

Identifier Type: -

Identifier Source: org_study_id