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

This study is currently recruiting participants.

Verified March 2013 by Mundipharma K.K.

Sponsor:

Information provided by (Responsible Party):

Mundipharma K.K.

ClinicalTrials.gov Identifier:

NCT01776411

First received: January 22, 2013

Last updated: March 8, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 22, 2013
Last Updated Date	March 8, 2013
Start Date ^ICMJE	January 2013
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 23, 2013)	Objective response rate (ORR) based on evaluation by image assessment committee [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01776411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
Official Title ^ICMJE	Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Recurrent or Refractory PTCL
Intervention ^ICMJE	Drug: forodesine hydrochloride
Study Arm (s)	Experimental: Single Arm Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily) Intervention: Drug: forodesine hydrochloride
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	49
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01776411
Other Study ID Numbers ^ICMJE	FDS-J02
Has Data Monitoring Committee	No
Responsible Party	Mundipharma K.K.
Study Sponsor ^ICMJE	Mundipharma K.K.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mundipharma K.K.
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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