Trial record 1 of 10 for:    kw-0761
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Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Aichi Medical University
Sponsor:
Information provided by (Responsible Party):
Ryuzo Ueda, MD, Aichi Medical University
ClinicalTrials.gov Identifier:
NCT01929486
First received: July 24, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Solid Tumor
Biological: Mogamulizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

Resource links provided by NLM:


Further study details as provided by Aichi Medical University:

Primary Outcome Measures:
  • Maximum tolerated dose(MTD) of Mogamulizumab [ Time Frame: from first administration until day 28 ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity(DLT) of Mogamulizumab [ Time Frame: from first administration until day 28 ] [ Designated as safety issue: Yes ]
  • Number of adverse events [ Time Frame: from first administration to 24 weeks after the final administration, an expected average of 32 weeks. ] [ Designated as safety issue: Yes ]
  • Cmax of Mogamulizumab [ Time Frame: from day 0 to 28 days after the final administration, an expected average of 12 weeks. ] [ Designated as safety issue: No ]
  • Ctrough of Mogamulizumab [ Time Frame: from day 0 to 28 days after the final administration, an expected average of 12 weeks. ] [ Designated as safety issue: No ]
  • AUC0-7day of Mogamulizumab [ Time Frame: from day 0 to 28 days after the final administration, an expected average of 12 weeks. ] [ Designated as safety issue: No ]
  • Rate of Treg decrease in PBMC compared to baseline [ Time Frame: from baseline to every 4 weeks until data cut off (expected date is June 2015) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response rate according to RECIST [ Time Frame: from baseline to every 12 weeks, until data cut off (expected date is June 2015) ] [ Designated as safety issue: No ]
  • Median progression free survival rate [ Time Frame: from baseline to every 12 weeks, until data cut off (expected date is June 2015) ] [ Designated as safety issue: No ]
  • Median Overall survival rate [ Time Frame: from baseline to every 12 weeks, until data cut off (expected date is June 2015) ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: February 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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, 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 secondary entry.
  15. Any other inadequacy for this study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929486

Locations
Japan
Aichi Medical University Recruiting
Nagoya, Aichi, Japan
Contact: Susumu Suzuki       tumorimm@aichi-med-u.ac.jp   
Sponsors and Collaborators
Aichi Medical University
  More Information

No publications provided

Responsible Party: Ryuzo Ueda, MD, Aichi Medical University
ClinicalTrials.gov Identifier: NCT01929486     History of Changes
Other Study ID Numbers: KW0761-IIT-01
Study First Received: July 24, 2013
Last Updated: September 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014