Clinical trial NCT01776411: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent or Refractory PTCL
Lead sponsor: Mundipharma K.K.
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Objective response rate (ORR) based on evaluation by image assessment committee
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime,
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto
country: Japan
facility: The Cancer Institute Hospital Japanese Foundation for Cancer Research
state: Tokyo
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kagoshima
country: Japan
facility: Imamura Bun-in Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Okayama,
country: Japan
facility: Okayama University Hospital
Study officials:
affiliation: National Cancer Center Hospital
name: Kensei Tobinai, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: