Recurrent or Refractory T/NK-cell MalignanciesPhase 1NCT00823355
Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
A Phase 1 study testing forodesine hydrochloride in people with Recurrent or Refractory T/NK-cell Malignancies, run by Mundipharma K.K. at 3 sites in Japan.
Trial summary
Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate pharmacokinetics (PK) of oral BCX1777. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Recurrent or Refractory T/NK-cell Malignancies
- 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
- 24 participants
- Where
- 3 sitesJapan
- Study dates
- Jan 2009to Aug 2013
- Phase
- Phase 1
- 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
- Histologically documented with histopathological diagnosis from biopsy, T/NK-cell malignancies (WHO classification). Precursor T-cell lymphoblastic leukemia/lymphoma (T-ALL/T-LBL) should be excluded in this study
- A patient with recurrent, relapse or refractory T/NK-cell malignancies who has received at lease one chemotherapeutic regimen
- Age 20 or greater
- Eastern Cooperative Oncology Group(ECOG) performance status:0,1.
- Able to be hospitalized at least for 15 days from the first dose
- In the case of subject with tumor cell rate of ≤25% in bone marrow, a patient who satisfies both of the following criteria.
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- Neutrophil count: ≥1,200/mm3
- Platelet count: ≥75,000/mm3
- In the case of CTCL, the tumor cell rate is handled as ≤25%.
- Adequate Liver function: AST, ALT ≤ 5.0 x upper limit of normal (ULN)
- Adequate Renal function: Creatinine Clearance (using cockcroft-Gault formula) ≥ 50mL/min
- Life expectancy of at least 3 months
- A patient who has given a written informed consent prior to the start of procedures proper to this study.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Investigational Site
Cyuo, Tokyo
Investigational Site
Nagasaki, Nagasaki
Investigational Site
Nagoya, Aichi-ken
About this study
Official title: A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate pharmacokinetics (PK) of oral BCX1777.
- 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
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
forodesine hydrochlorideDrug
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
forodesine hydrochlorideDrug
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
forodesine hydrochlorideDrug
Cohort 4: 400mg / body (4 x 100mg tablets once daily)
| Study group | Role | What they receive |
|---|---|---|
| BCX1777 | Experimental | Not described Receives: Drug: forodesine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
Measured: March 2010
To evaluate pharmacokinetics (PK) of oral BCX1777
Measured: March 2010
Secondary outcomes (4)
To evaluate pharmacodynamics (PD) of oral BCX1777
Measured: March 2010
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
Measured: March 2010
To evaluate the efficacy of oral BCX1777
Measured: March 2010
To analyze cell surface marker in peripheral blood mononuclear cell
Measured: March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent or Refractory T/NK-cell MalignanciesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823355
- Sponsor's protocol ID
- BCX1777-J01
- Status last verified
- Sep 2013
- First submitted
- 8 Jan 2009
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogura M, Tsukasaki K, Nagai H, Uchida T, Oyama T, Suzuki T, Taguchi J, Maruyama D, Hotta T, Tobinai K. Phase I study of BCX1777 (forodesine) in patients with relapsed or refractory peripheral T/natural killer-cell malignancies. Cancer Sci. 2012 Jul;103(7):1290-5. doi: 10.1111/j.1349-7006.2012.02287.x. Epub 2012 Apr 30.
PubMed 22448814
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
- ClinicalTrials.gov ID
- NCT00823355
- Acronym / sponsor ID
- BCX1777-J01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mundipharma K.K.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2013 (actual)
- First posted
- 15 Jan 2009 (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.
Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate pharmacokinetics (PK) of oral BCX1777.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCX1777 | Experimental | Drug: forodesine hydrochloride |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically documented with histopathological diagnosis from biopsy, T/NK-cell malignancies (WHO classification). Precursor T-cell lymphoblastic leukemia/lymphoma (T-ALL/T-LBL) should be excluded in this study
- A patient with recurrent, relapse or refractory T/NK-cell malignancies who has received at lease one chemotherapeutic regimen
- Age 20 or greater
- Eastern Cooperative Oncology Group(ECOG) performance status:0,1.
- Able to be hospitalized at least for 15 days from the first dose
Key exclusion criteria (1 listed)
- -
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 hydrochlorideCohort 1: 100mg / body (1 x 100mg tablet once daily) | Drug | BCX1777 |
| forodesine hydrochlorideCohort 2: 200mg / body (2 x 100mg tablets once daily) | Drug | BCX1777 |
| forodesine hydrochlorideCohort 3: 300mg / body (3 x 100mg tablets once daily) | Drug | BCX1777 |
| forodesine hydrochlorideCohort 4: 400mg / body (4 x 100mg tablets once daily) | Drug | BCX1777 |
Primary outcome
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
Time frame: March 2010
To evaluate pharmacokinetics (PK) of oral BCX1777
Time frame: March 2010
4 secondary outcomes
To evaluate pharmacodynamics (PD) of oral BCX1777
Time frame: March 2010
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
Time frame: March 2010
To evaluate the efficacy of oral BCX1777
Time frame: March 2010
To analyze cell surface marker in peripheral blood mononuclear cell
Time frame: March 2010
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 23 Sep 2013.
- Derived from this study: PubMed 22448814Ogura M, Tsukasaki K, Nagai H, Uchida T, Oyama T, Suzuki T, Taguchi J, Maruyama D, Hotta T, Tobinai K. Phase I study of BCX1777 (forodesine) in patients with relapsed or refractory peripheral T/natural killer-cell malignancies. Cancer Sci. 2012 Jul;103(7):1290-5. doi: 10.1111/j.1349-7006.2012.02287.x. Epub 2012 Apr 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing forodesine hydrochloride in people with Recurrent or Refractory T/NK-cell Malignancies, run by Mundipharma K.K. at 3 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 13 inclusion and 1 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 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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?
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies. (time frame: March 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00823355, which also lists 1 linked publication.
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 23 Sep 2013.