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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mundipharma K.K.
ClinicalTrials.gov Identifier:
NCT01776411
First received: January 22, 2013
Last updated: February 19, 2015
Last verified: February 2015
  Purpose

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).


Condition Intervention Phase
Recurrent or Refractory PTCL
Drug: forodesine hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by Mundipharma K.K.:

Primary Outcome Measures:
  • Objective response rate (ORR) based on evaluation by image assessment committee [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily)
Drug: forodesine hydrochloride

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01776411

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

No publications provided

Responsible Party: Mundipharma K.K.
ClinicalTrials.gov Identifier: NCT01776411     History of Changes
Other Study ID Numbers: FDS-J02
Study First Received: January 22, 2013
Last Updated: February 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 01, 2015