Recurrent or Refractory PTCLPhase 1/2NCT01776411
Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
A Phase 1/2 study testing forodesine hydrochloride in people with Recurrent or Refractory PTCL, run by Mundipharma K.K. at 21 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Recurrent or Refractory PTCL
- What is being tested?
- forodesine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 21 sitesJapan
- Study dates
- Jan 2013to 26 Apr 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
National Cancer Center Hospital
Chūō, Tokyo, 104-0045
University of Fukui Hospital
Fukui, 910-1193
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Fukuoka University Hospital
Fukuoka, 814-0180
Tokai University Hospital
Isehara, Kanagawa, 259-1143
Shimane University Hospital
Izumo, Shimane, 693-8501
Imamura Bun-in Hospital
Kagoshima, 890-0064
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
The Cancer Institute Hospital Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550,
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Gunma University Hospital
Maebashi, Gunma, 371-8511
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 466-8650
Okayama University Hospital
Okayama, 700-8558
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Osaka University Hospital
Suita, Osaka, 565-0871
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834
About this study
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
- Being tested
- forodesine hydrochloride
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forodesine hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Drug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily) Receives: Drug: forodesine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) based on evaluation by image assessment committee
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2016
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Refractory PTCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kensei Tobinai, MD,PhD, Principal investigator, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776411
- Sponsor's protocol ID
- FDS-J02
- Status last verified
- May 2017
- First submitted
- 22 Jan 2013
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT01776411
- Acronym / sponsor ID
- FDS-J02
- Conditions
- Recurrent or Refractory PTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Mundipharma K.K.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: forodesine hydrochlorideDrug: forodesine hydrochloride 600 mg / body/day (3 x 100 mg capsules twice daily) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| forodesine hydrochloride | Drug | Single Arm |
Primary outcome
Objective response rate (ORR) based on evaluation by image assessment committee
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kensei Tobinai, MD,PhD principal investigator
National Cancer Center Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing forodesine hydrochloride in people with Recurrent or Refractory PTCL, run by Mundipharma K.K. at 21 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) based on evaluation by image assessment committee (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.