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

NCT ID: NCT01776411

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-04-26

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).

Conditions

Recurrent or Refractory PTCL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

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

Group Type: EXPERIMENTAL

forodesine hydrochloride

Intervention Type: DRUG

Interventions

forodesine hydrochloride

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kensei Tobinai, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Hospital

Locations

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Osaka University Hospital

Suita, Osaka, Japan

Shimane University Hospital

Izumo, Shimane, Japan

Tochigi Cancer Center

Utsunomiya, Tochigi, Japan

National Cancer Center Hospital

Chūō, Tokyo, Japan

The Cancer Institute Hospital Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

University of Fukui Hospital

Fukui, , Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Fukuoka University Hospital

Fukuoka, , Japan

Imamura Bun-in Hospital

Kagoshima, , Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Okayama University Hospital

Okayama, , Japan

Countries

Japan

Other Identifiers

FDS-J02

Identifier Type: -

Identifier Source: org_study_id