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

NCT01776411 | Completed Phase 1

• 1 other identifier: FDS-J02
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 21

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

Outcome Measures

Primary Outcomes (1)

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

  2 years

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: forodesine hydrochloride

Interventions

forodesine hydrochloride DRUG

Single Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma K.K.: lead

Study Sites (21)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Gunma University Hospital

Maebashi, Gunma, 371-8511, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1143, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

Tochigi Cancer Center

Utsunomiya, Tochigi, 320-0834, Japan

Location

National Cancer Center Hospital

Chūō, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital Japanese Foundation for Cancer Research

Koto, Tokyo, 135-8550,, Japan

Location

University of Fukui Hospital

Fukui, 910-1193, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Imamura Bun-in Hospital

Kagoshima, 890-0064, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kensei Tobinai, MD,PhD

  National Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 28, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: April 26, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

JP (21)