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Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients

Primary Purpose

Recurrent or Refractory PTCL

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
forodesine hydrochloride
Sponsored by
Mundipharma K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Refractory PTCL

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Japanese patients at least 20 years of age.
  • Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion. In this study, peripheral T-cell lymphoma is defined as the following mature T-cell/NK-cell neoplasms found in the 4th edition of the WHO Classification.
  • Recurrent/refractory patients with a treatment history of at least one regimen.
  • Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
  • Patients expected to survive for at least 3 months.
  • ECOG PS 0-1.
  • Patients with adequate hemopoietic efficacy, liver and kidney function.
  • Patients from whom written consent has been obtained prior to study initiation.

Exclusion Criteria:

  • Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
  • Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
  • Patients who received another study drug within 28 days prior to initial administration of the study drug.
  • Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
  • Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
  • Patients with cerebral metastasis or central nervous system lesion or a past history.
  • Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
  • Patients with severe cardiovascular disease.
  • Patients with congenital long QT syndrome.
  • Patients with QTcF >0.48 sec.
  • Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
  • Patients positive for CMV antigen on immunological investigation.
  • Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
  • Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.

Sites / Locations

  • National Hospital Organization Nagoya Medical Center
  • Nagoya Daini Red Cross Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Gunma University Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Hyogo Cancer Center
  • Tokai University Hospital
  • Tohoku University Hospital
  • Osaka University Hospital
  • Shimane University Hospital
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • The Cancer Institute Hospital Japanese Foundation for Cancer Research
  • University of Fukui Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Fukuoka University Hospital
  • Imamura Bun-in Hospital
  • National Hospital Organization Kumamoto Medical Center
  • University Hospital, Kyoto Prefectural University of Medicine
  • Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily)

Outcomes

Primary Outcome Measures

Objective response rate (ORR) based on evaluation by image assessment committee

Secondary Outcome Measures

Full Information

First Posted
January 22, 2013
Last Updated
May 9, 2017
Sponsor
Mundipharma K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT01776411
Brief Title
Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
Official Title
Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase I portion: To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day) for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics. Phase II portion: To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Refractory PTCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily)
Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride
Primary Outcome Measure Information:
Title
Objective response rate (ORR) based on evaluation by image assessment committee
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Japanese patients at least 20 years of age. Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion. In this study, peripheral T-cell lymphoma is defined as the following mature T-cell/NK-cell neoplasms found in the 4th edition of the WHO Classification. Recurrent/refractory patients with a treatment history of at least one regimen. Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed. Patients expected to survive for at least 3 months. ECOG PS 0-1. Patients with adequate hemopoietic efficacy, liver and kidney function. Patients from whom written consent has been obtained prior to study initiation. Exclusion Criteria: Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug. Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug. Patients who received another study drug within 28 days prior to initial administration of the study drug. Patients who received antibody therapy within 100 days prior to initial administration of the study drug. Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug. Patients with cerebral metastasis or central nervous system lesion or a past history. Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years. Patients with severe cardiovascular disease. Patients with congenital long QT syndrome. Patients with QTcF >0.48 sec. Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay. Patients positive for CMV antigen on immunological investigation. Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug. Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kensei Tobinai, MD,PhD
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime,
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Cancer Center
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1143
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550,
Country
Japan
Facility Name
University of Fukui Hospital
City
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Imamura Bun-in Hospital
City
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama,
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients

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