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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01776411
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Mundipharma K.K.

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date May 11, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2016   (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 ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Refractory PTCL
Intervention  ICMJE Drug: forodesine hydrochloride
Study Arms  ICMJE 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 Completed
Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
49
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 26, 2017
Actual Primary Completion Date March 2016   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776411
Other Study ID Numbers  ICMJE FDS-J02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mundipharma K.K.
Study Sponsor  ICMJE Mundipharma K.K.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kensei Tobinai, MD,PhD National Cancer Center Hospital
PRS Account Mundipharma K.K.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP