Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929486
Recruitment Status : Unknown
Verified February 2016 by Ryuzo Ueda, MD, Aichi Medical University.
Recruitment status was:  Active, not recruiting
First Posted : August 28, 2013
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Ryuzo Ueda, MD, Aichi Medical University

Brief Summary:
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: Mogamulizumab Phase 1

Detailed Description:

This study consists of phase Ia and Ib portions for patients with solid tumors.

Phase Ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and 1.0mg/kg of Mogamulizumab.

Phase Ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of Mogamulizumab based on the phase Ia portion to pursue safer and immunologically more efficient dose.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.
Study Start Date : February 2013
Estimated Primary Completion Date : June 2016

Arm Intervention/treatment
Experimental: <Phase Ia> Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg
<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
Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.
Other Name: KW-0761

Experimental: <Phase Ib> Mogamulizumab of the tolerated dose
<Phase Ib> Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week.
Biological: Mogamulizumab
Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.
Other Name: KW-0761

Experimental: <Phase Ib> Mogamulizumab 0.1mg/kg
<Phase Ib> Mogamulizumab 0.1mg/kg will be administered 8 times every week.
Biological: Mogamulizumab
Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.
Other Name: KW-0761




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

Secondary Outcome Measures :
  1. Objective tumor response rate according to RECIST [ Time Frame: from baseline to every 12 weeks, until data cut off ]
  2. Median progression free survival rate [ Time Frame: from baseline to every 12 weeks, until data cut off (expected date is March 2016) ]
  3. Median Overall survival rate [ Time Frame: from baseline to every 12 weeks, until data cut off ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed, CCR4 negative lung, stomach, esophageal, ovarian or skin cancer.
  2. Patients with therapy-resistant cancer. Patients with recurrent cancer or advanced cancer who refused standard therapies.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2.
  4. Patients should be 20 years or older at the time of informed consent.
  5. 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 %
  6. 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).
  7. Given written informed consent.
  8. Patients who can be hospitalized from the day of first administration to the next day.
  9. Patients who have target lesions measurable by RECIST ver.1.1.
  10. Life expectancy >= 3 months.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929486


Locations
Layout table for location information
Japan
Aichi Medical University
Nagoya, Aichi, Japan
Sponsors and Collaborators
Aichi Medical University
Layout table for additonal information
Responsible Party: Ryuzo Ueda, MD, Aichi Medical University
ClinicalTrials.gov Identifier: NCT01929486    
Other Study ID Numbers: KW0761-IIT-01
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Recurrence
Disease Attributes
Pathologic Processes
Mogamulizumab
Antineoplastic Agents