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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00501735




Registration number
NCT00501735
Ethics application status
Date submitted
12/07/2007
Date registered
16/07/2007
Date last updated
23/01/2012

Titles & IDs
Public title
Forodesine in the Treatment of Cutaneous T-Cell Lymphoma
Scientific title
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
Secondary ID [1] 0 0
BCX1777-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous T-cell Lymphoma (CTCL), 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Forodesine 200 mg

Treatment: Drugs: Forodesine 200 mg
2 x 100mg tablets once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA.
Timepoint [1] 0 0
Duration of Study
Secondary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
Duration of Study
Secondary outcome [2] 0 0
Time to and duration of objective response in cutaneous manifestations
Timepoint [2] 0 0
Duration of Study
Secondary outcome [3] 0 0
Time to loss of objective response
Timepoint [3] 0 0
Duration of Study
Secondary outcome [4] 0 0
Objective response rate, time to and duration of extracutaneous manifestations
Timepoint [4] 0 0
Duration of Study
Secondary outcome [5] 0 0
Health related quality of life
Timepoint [5] 0 0
Duration of Study

Eligibility
Key inclusion criteria
- Males or non-pregnant females aged =18 years;

- Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sezary
syndrome, documentation of diagnosis by histologic examination should be available;

- Subjects with CTCL stages IB, IIA, IIB, III, or IVA at the screening visit (i.e. stage
refers to stage at study entry) and who have persistent, progressive, or recurrent
disease during or following treatment with at least three forms of systemic therapy,
one of which must have been oral bexarotene, unless treatment with oral bexarotene was
not tolerated or was medically contraindicated;

- Anticipated life expectancy greater than 6 months;

- Performance status of 0, 1, or 2 by Eastern Cooperative Oncology Group (ECOG)
criteria;

- Females of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of study treatment;

- Females of childbearing potential and sexually active males, if indicated, must be
willing and able to use method(s) of contraception that are adequate to prevent or
minimize the risk of pregnancy for the duration of the study;

- Written informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB)
(note: presence of lymphadenopathy is permitted);

- Previous treatment with Forodesine;

- ECOG performance status >2;

- Concomitant use of any anti-cancer therapy or immune modifier;

- Concomitant use of any investigational agent or device;

- Concurrent treatment with any other anti-CTCL therapy, or radiation therapy [topical
corticosteroids (classes 1 and 2 prohibited) or low dose oral corticosteroids (=10
mg/day prednisone or equivalent) will not be excluded, but if used, must be a stable
dose and schedule during the four weeks immediately prior to study entry];

- Use of previous therapies for CTCL within the timeframes specified below:

1. Phototherapy in the previous 30 days;

2. Electron beam therapy, photopheresis, systemic anticancer therapy, interferon
therapy, or other investigational therapy in the previous 30 days;

3. Oral retinoid (including bexarotene) in the previous 30 days

4. Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 days

5. Vorinostat or other HDAC inhibitor within previous 30 days

6. Any investigational therapy within the previous 30 days;

- ALT or AST >3 times ULN or alkaline phosphatase >2 times ULN;

- Calculated creatinine clearance =50 mL/min or serum creatinine =1.8 mg/dL;

- Serum potassium <3.3 mg/dL or >5.5 mg/dL;

- Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism;

- Recent (in past 6 months) medically significant cardiac event (i.e., myocardial
infarction, cardiac surgery);

- Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or
presence of a medically significant dysrhythmia;

- Presence of any of the following ECG findings:

1. Congenital long QT syndrome;

2. QTc interval >480 msec (Bazett's correction);

- Presence of uncontrolled hypertension manifested by systolic blood pressure =160 mmHg
and/or diastolic blood pressure =90 mmHg;

- Hemoglobin <9.0 gm/dL (intermittent red blood cell transfusions permitted);

- Absolute neutrophil count <1500 cells/mm3;

- Platelet count <75,000/mm3;

- Requirement for neutrophil or platelet growth factor therapy or administration of such
therapy in the previous 30 days;

- CD4 count <200/mm3;

- Documented current active infection with HIV, Hepatitis B, Hepatitis C, and/or CMV;

- Presence of uncontrolled bacterial or viral infection (subject may be receiving
chronic antimicrobial therapy); or,

- History of culture-documented bacteremia in the previous 2 weeks;

- Recent (i.e., in past 2 weeks) change in doses or regimens of medications used for any
chronic non-oncologic condition for reasons of worsening of the chronic illness
(change in doses of chronic medications associated with improvement in a chronic
illness are not exclusionary);

- Presence of any acute or chronic non-oncologic disease which, in the opinion of the
investigator, is medically uncontrolled;

- Coexistent second malignancy or history of prior malignancy within previous 5 years
[excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia
(carcinoma-in-situ) that has been treated curatively]. Surgically resected
nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in previous 6
months is permitted; and,

- Any significant medical or psychiatric condition that, in the opinion of the
investigator, might prevent the subject from complying with all required study
procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Finland
State/province [18] 0 0
Helsinki
Country [19] 0 0
France
State/province [19] 0 0
Clermont-Ferrand
Country [20] 0 0
France
State/province [20] 0 0
Creteil
Country [21] 0 0
France
State/province [21] 0 0
Montpellier
Country [22] 0 0
France
State/province [22] 0 0
Pessac
Country [23] 0 0
France
State/province [23] 0 0
Reims CEDEX
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Jena
Country [27] 0 0
Germany
State/province [27] 0 0
Kiel
Country [28] 0 0
Germany
State/province [28] 0 0
Mannheim
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Italy
State/province [30] 0 0
Firenze
Country [31] 0 0
Italy
State/province [31] 0 0
Milan
Country [32] 0 0
Italy
State/province [32] 0 0
Rome
Country [33] 0 0
Italy
State/province [33] 0 0
Torino
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Switzerland
State/province [35] 0 0
Zurich
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioCryst Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up
to 50 sites in North America, Europe and Australia. This study is designed to assess
objective response (OR) [complete response (CR) or partial response (PR)] in subjects with
cutaneous manifestations of CTCL with a requirement for maintenance of such objective
response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally,
this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB,
III, or IVA treated with oral forodesine.
Trial website
https://clinicaltrials.gov/show/NCT00501735
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nashat Gabrail, MD
Address 0 0
Gabrail Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications