Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanc... | NCT01929486

NCT01929486

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
<Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg	Experimental	<Phase Ia> Dose-escalation method with Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg. Mogamulizumab will be administered 8 times every week.	Biological: Mogamulizumab
<Phase Ib> Mogamulizumab of the tolerated dose	Experimental	<Phase Ib> Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week.	Biological: Mogamulizumab
<Phase Ib> Mogamulizumab 0.1mg/kg	Experimental	<Phase Ib> Mogamulizumab 0.1mg/kg will be administered 8 times every week.	Biological: Mogamulizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mogamulizumab	Biological	Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.	<Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum tolerated dose(MTD) of Mogamulizumab		from first administration until day 28
Dose limiting toxicity(DLT) of Mogamulizumab		from first administration until day 28
Number of adverse events		from first administration to 24 weeks after the final administration, an expected average of 32 weeks.
Cmax of Mogamulizumab		from day 0 to 28 days after the final administration, an expected average of 12 weeks.
Ctrough of Mogamulizumab		from day 0 to 28 days after the final administration, an expected average of 12 weeks.
AUC0-7day of Mogamulizumab		from day 0 to 28 days after the final administration, an expected average of 12 weeks.
Rate of Treg decrease in PBMC compared to baseline		from baseline to every 4 weeks until data cut off

Secondary Outcomes

Measure	Description	Time Frame
Objective tumor response rate according to RECIST		from baseline to every 12 weeks, until data cut off
Median progression free survival rate		from baseline to every 12 weeks, until data cut off (expected date is March 2016)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer.
Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies.
Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2.
Patients should be 20 years or older at the time of informed consent.
No serious dysfunction of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ; 1) WBC count : >=1,500/mm3 2) Hemoglobin : >=8.0g/dL 3) Platelet count : >=75,000/mm3 4) Serum total bilirubin : <=2.0 x ULN 5) AST and ALT : <=2.5 x ULN (Patients with hepatic infiltration which is attributed to primary disease<=5.0 x ULN) 6) Serum creatinine : <=1.5 mg/dL 7) SpO2 : >=93 % 8) ECG : No abnormal findings. 9) EF : >=50 %
Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
Given written informed consent.
Patients who can be hospitalized from the day of first administration to the next day.
Patients who have target lesions measurable by RECIST ver.1.1.
Life expectancy >= 3 months.

Exclusion Criteria:

Patients with HIV antibody positive.
Patients with HCV antibody positive.
Patients with autoimmune disease.
Patients with HBs antigen or HBV-DNA positive.
History of serious anaphylaxis induced by antibody preparation.
Patients with double cancer.
Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease.
Pregnant or breast-feeding females and females who have a possibility of pregnancy.
Patients with active infection.
Patients with psychosis or dementia.
Patients who need continuous systemic administration of adrenocorticosteroid.
Patients who have received hematopoietic stem cell transplantation.
Patients who have presence or suspicion of CNS involvement.
Patients who are administered the other investigational product within 4 weeks of the entry.
Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry.
Any other inadequacy for this study.

Facility	Status	City	State	ZIP	Country	Contacts
Aichi Medical University		Nagoya	Aichi-ken		Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37729184	Derived	Fujikawa K, Saito T, Kurose K, Kojima T, Funakoshi T, Sato E, Kakimi K, Iida S, Doki Y, Oka M, Ueda R, Wada H. Integrated analysis of phase 1a and 1b randomized controlled trials; Treg-targeted cancer immunotherapy with the humanized anti-CCR4 antibody, KW-0761, for advanced solid tumors. PLoS One. 2023 Sep 20;18(9):e0291772. doi: 10.1371/journal.pone.0291772. eCollection 2023.
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