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

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).

Study Overview

• Status: Completed
• Conditions: Recurrent or Refractory PTCL
• Intervention / Treatment: Drug: forodesine hydrochloride

• Study Type: Interventional
• Enrollment (Anticipated): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukui, Japan, 910-1193
    • University of Fukui Hospital
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Kagoshima, Japan, 890-0064
    • Imamura Bun-in Hospital
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Kyoto, Japan, 602-8566
    • University Hospital, Kyoto Prefectural University of Medicine
  • Okayama,, Japan, 700-8558
    • Okayama University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8650
      • Nagoya Daini Red Cross Hospital
    • Nagoya, Aichi, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime,
    • Matsuyama, Ehime,, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Gunma University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1143
      • Tokai University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Shimane
    • Izumo, Shimane, Japan, 693-8501
      • Shimane University Hospital
  • Tochigi
    • Utsunomiya, Tochigi, Japan, 320-0834
      • Tochigi Cancer Center
  • Tokyo
    • Chuo, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto, Tokyo, Japan, 135-8550,
      • The Cancer Institute Hospital Japanese Foundation for Cancer Research

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily)	Drug: forodesine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR) based on evaluation by image assessment committee	2 years

Collaborators and Investigators

• Sponsor: Mundipharma K.K.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 26, 2017

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Disease Attributes; Lymphoma; Recurrence; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: FDS-J02