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

February 16, 2016 updated by: Ryuzo Ueda, MD, Aichi Medical University
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan
        • Aichi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • KW-0761

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aichi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KW0761-IIT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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