1-8-1 Shimomeguro, Meguro-ku, Tokyo 153-8926, Japan
+81-120-870-088
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Merck Serono Co., Ltd., Japan
1-8-1 Shimomeguro, Meguro-ku, Tokyo 153-8926, Japan
+81-120-870-088
-
completed
Oct. 30, 2013
24
Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
treatment purpose
1
(1)Japanese male or female subjects aged greater than or equal to 20 years at the time of informed
(2)consent signature
(3)Histologically or cytologically confirmed cancer
(4)Refractory or recurrent advanced late stage solid tumors without available therapeutic options which are likely to provide patient benefit (failure and/or intolerance to standard anti-cancer therapy)
(5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
(6)Life expectancy of at least 3 months
(7)Written informed consent given before any trial-related activities are carried out
(1)Subjects with symptomatic brain metastases
(2)Subjects who received total resection or irradiation of the target lesion
(3)Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy, antibody therapy, tyrosine kinase inhibitors, and any investigational agent
(4)Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004 at Week 1
(5)Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)
(6)Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)
(7)Magnesium of less than 0.9 milligram per deciliter (mg/dL)
(8)Abnormal organ or bone marrow function as defined in the protocol
(9)Received immunosuppressive agents (including systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent) within 4 weeks before the first administration of Sym004 at Week 1
(10)Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the Investigator
(11)Known human immunodeficiency virus (HIV) positive, active Hepatitis B or C, or uncontrolled allergic conditions or allergy to Sym004 or its components
(12)Clinically significant cardiac disease or concurrent, uncontrolled medical condition
(13)Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies
(14)Other protocol defined exclusion criteria could apply
20age old over
No limit
Both
Solid Tumors
investigational material(s)
Generic name etc : Sym004
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Sym004 will be administered intravenously either weekly at 6 to 12 milligram per kilogram (mg/kg) or biweekly at 18 mg/kg from Week 1 until unacceptable toxicity, disease progression, or consent withdrawal.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
safety
(1)Dose Limiting Toxicity [ Time Frame: Up to Week 4 ] [ Designated as safety issue: Yes ]
(2)Number of subjects with Adverse Events [ Time Frame: Up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: Yes ]
efficacy
pharmacokinetics
pharmacodynamics
(1)Pharmacokinetic profile of Sym004: Area under curve (AUC), Half-life (t1/2 ), Clearance (CL), Volume of distribution at the elimination phase (Vz ), Maximum concentration (Cmax ), Trough concentration (Ctrough), Time to reach Cmax (tmax ) [ Time Frame: Up to 8 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(2)Best overall response rate [ Time Frame: Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(3)Duration of overall response [ Time Frame: Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(4)Disease control rate [ Time Frame: Week 7 and thereafter every 6 weeks, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(5)Duration of disease control [ Time Frame: Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(6)Time to progression [ Time Frame: Time from enrollment until the date of objectively documented disease progression, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(7)Progression-free survival time [ Time Frame: Time from enrollment until the date of objectively documented disease progression or death, up to 4 weeks after the last Sym004 administration ] [ Designated as safety issue: No ]
(8)Change from Baseline in anti-drug antibody (ADA) titer at Weeks 1 and 5 [ Time Frame: Baseline, Weeks 1 and 5 ] [ Designated as safety issue: No ]
(9)Epidermal growth factor receptor levels in skin tissues [ Time Frame: Weeks 1 and 5 ] [ Designated as safety issue: No ]
Merck Serono Co., Ltd., Japan
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Institutional Review Board of National Cancer Center
